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Programme

The full programme will be available on demand for 30 days after the conference finishes, so if you miss a session or find your preferred sessions clash, all delegates will be able to access them at their leisure at a later date. Presentations will then be added to the RQA website so delegates have lifetime access.

DELEGATE BROCHURE DOWNLOAD

Click each presentation title for more information.

*please note that the programme below is submit to change*

TUESDAY 10TH NOVEMBER

PLENARY SESSIONS

09.00 OPENING ADDRESS, Tim Stiles, RQA Chair

OPENING ADDRESS

RQA's Chair opens the conference.

09.05 WELCOME, Robert Gaertner, Veeva

09.15 KEYNOTE SPEAKER, Kriss Akabusi, The Akabusi Company

10.30 Networking Break

11.00 COVID-19 GXP INSIGHTS AND THE NEW NORMALDave Nickerson, Richard Crossland, Stuart Pullen, Joanne Donald, Vicki Edwards and Steve Rogers. Chairs: Sameera Ibrahim and Michael Smith

12.30 Networking Break and Lunch


CONCURRENT STREAMS 

STREAM ONE:

THE FUTURE OF QUALITY

13.30 TRANSFORMING QUALITY FOR 2020 AND BEYONDRobert Gaertner, Veeva Vault Quality
14.00 THE MULTICULTURAL AUDITOR, Andrew Waddell, Tower Mains
14.30 INDUSTRY 4.0 AND THE TOTAL COST OF QUALITYStephen McCarthy, Sparta Systems
15.00 QA OF THE FUTURE: INDUSTRY THINKTANK OUTCOMESharmila Sabaratnam, Ernst & Young

15.30 Networking Break

16.00 THIRD PARTY RISK MANAGEMENT FROM SELECTION TO TERMINATION/RENEWALOliver Steck, Deloitte & Touche LLP
16.30 USING BIG DATA TO TAKE QUALITY BEYOND COMPLIANCE, Sue Marchant, MasterControl Inc.
17.00 OPTIMISING TRIAL DESIGN AND RISK-BASED OVERSIGHT THROUGH QUALITY BY DESIGN, Ann Meeker O’Connell, Vertex Pharmaceuticals

17.30 Networking Event

INDUSTRY INSIGHTS

18.30 WHO’S ON FIRST: DEVELOPING THE BEST INSPECTION TEAMKara Harrison, FDA Quality + Regulatory Consultants
19.00 DUE DILIGENCE IN VENDOR SELECTIONChris Rush, FDA Quality + Regulatory Consultants
19.30 OFF ROADING REMOTE AUDIT COMMUNICATION AND PLANNINGErich Zirzow, FDA Quality + Regulatory Consultants
20.00 AUDITING TECHNIQUES FOR CAUSE/DIRECTED AUDITSTammy Lesko, FDA Quality + Regulatory Consultants
20.30 METRICS THAT MATTERMichelle Copeland, FDA Quality + Regulatory Consultants

STREAM TWO:

INDUSTRY INSIGHTS

14.00 HOW LONG SHOULD AN EFFECTIVE AUDIT TAKE?Christine Henderson, Eisai and Marina Freiberga, Tower Mains
14.30 QUALITY IN RESEARCH: A FIT FOR PURPOSE APPROACHAlessandra Grande, Merck
15.00 QUALITY ASSURANCE SYSTEMS IN RUSSIAMaria Flerova, LLC STPF POLYSAN

15.30 Networking Break

16.00 RISK BASED AUDITING - DEVELOPING A QA AUDIT STRATEGY AND EXECUTION PLANMilind Nadgouda, RiverArk Limited
16.30 INTRODUCTION TO BLOCKCHAIN AND AN EARLY LOOK INTO SOME PROMISING USE CASES IN PHARMAScott Askin, Novartis
17.00 SETTING UP BACK OFFICE OPERATION IN INDIA TO SUPPORT GLOBAL CLINICAL TRIALSMarian Mutch, Covance

17.30 Networking Event

18.30 THE BASIC QUALITY MANAGEMENT SYSTEM FOR PV PROCESSES REQUIRED IN THE EU, Laurence Richard, Audithem
19.00 AGILE DEVELOPMENT FOR CLINICAL RESEARCH SYSTEMSAlan Yeomans, Viedoc Technologies (formerly PCG Solutions)
19.30 HOW TO MAKE SURE THE QUALITY IS AS IT SHOULD BE OR WHERE DOES TRUST COME IN WHEN YOUR NAME IS AT STAKE?Willi Ramseier, QVRAM GmbH
20.00 IMPROVEMENT OF THE INTERNAL AUDIT TASK SELECTION PROCESS - PRIORITY CHECKS USING RISK SCORING TOOLSSooyeon Yang, AMC
20.30 HOW TO WRITE A VALIDATION OR QUALITY ASSURANCE PLAN – TO BE ABLE TO TRUST THE OUTCOME AND SIGN THE REPORTWilli Ramseier, QVRAM GmbH

STREAM THREE: 

IT

14.00 QUALITY DATA ANALYTICS: GETTING STARTED, OPTIMISING UNDERSTANDING AND CROSS-COMPANY SHARINGTimothe Menard, F. Hoffmann - La Roche Ltd and Jennifer Emerson, Boehringer-Ingelheim
14.30 AI: VALIDATION CHALLENGES, Renato Panza, Roche
15.00 AI: VALIDATING COMPUTER SYSTEMS WITH A MIND OF THEIR OWNRichard Brown, ADAMAS Consulting

15.30 Networking Break

16.00 CSA CRITICAL THINKINGOliver Hermann, QFINITY 
16.30 CLOUD BENEFITS IN LIFE SCIENCES, David Blewitt
17.00 IT QA CLINICJoanne Donald, Sarah Pickersgill, Keith Thornley, Matt Davies

17.30 Networking Event

18.30 PROVIDING QUALITY ASSURANCE WITH EVERCHANGING TECHNOLOGYMilind Nadgouda and Yogesh Agarwal, RiverArk Ltd.



WEDNESDAY 11TH NOVEMBER

STREAM ONE:

INDUSTRY INSIGHTS

07.30 MANAGEMENT OF MULTI SITE STUDIES - CHALLENGES AND SOLUTIONSLabhu Sanghani, Jai Research Foundation
08.00 OUTSOURCING OF NON CLINICAL STUDIES:ENSURING QUALITY AND COMPLIANCE FOR CARE, HOUSING AND CONTAINMENT OF BIOLOGICAL TEST SYSTEMLabhu Sanghani, Jai Research Foundation
08.30 DO ANALYSTS REQUIRE QUALITY ASSURANCE? FROM A GLP PERSPECTIVE, Smit Patel, Jai Research Foundation

GOOD CLINICAL PRACTICE 

09.00 HINDSIGHT: THE IMPORTANCE OF QTLS TO CLINICAL DEVELOPMENTWilliam Lawton, Risk Based Approach Ltd
09.30 HINDSIGHT: IMPACT OF DI GUIDANCETBC
10.00 HINDSIGHT: EMA TMF GUIDANCE, TBC

10.30 Networking break 

11.00 HERE AND NOW: REMOTE AUDITINGCathy Dove, Dove Quality Solutions
11.30 HERE AND NOW: VENDOR QUALITY MANAGEMENTHanna Preus, Opiant Pharmaceuticals
12.00 HERE AND NOW:EXPERIENCE OF OFFICE BASED INSPECTIONS, Anita Hawkins, GSK

12.30 Networking break and lunch

13.30 HERE AND NOW: ELIMINATE SILOS, DRIVE GLOBAL ALIGNMENT ACROSS CLINICAL AND QUALITY, Tieme Stoutjesdijk, Veeva Systems
14.00 FUTURE SHOCK: IMPACT ASSESSMENT OF ICH RENOVATIONKerstin Koenig, Bristol-Myer Squibb and Rebecca Stanbrook, Novartis
14.30 VIRTUAL TRIALS: BRINGING THE TRIAL TO THE PATIENTFiona Maini
15.00 VIRTUAL TRIALS: FUTURE NOWFatemeh Jami, Medical Research Network Ltd

15.30 Networking break

16.00 GOOD CLINICAL PRACTICE QA CLINIC, Patricia Henley, London School of Hygiene and Tropical Medicine and Michael Smith, 

17.30 QUIZ

INDUSTRY INSIGHTS

18.30 OPPORTUNITIES AND CHALLENGES TO CONDUCTING REMOTE VISITS , Juliet Hulse, Illingworth Research Group
19.00 WHY IS IT CALLED QMS? THERE WAS NEVER A BETTER TIME FOR A CONTROLLED REASSESS OF YOUR STRATEGIES AND FRAMEWORK (QMS) Willi Ramseier, QVRAM GmbH
19.30 BUSINESS RESILIENCE AND EMBRACING TECHNOLOGY DURING COVID-19 - THE GOOD, THE BAD AND THE UGLYMilind Nadgouda and Yogesh Agarwal, RiverArk Ltd


STREAM TWO:

INDUSTRY INSIGHTS

07.30 PREVALENCE OF A QUALITY CULTURE DRIVING DATA INTEGRITY- A GMP VS GLP PERSPECTIVE, Joyce KO
08.00 FUNDAMENTAL CONSIDERATIONS IN THE RESEARCH AND CLINICAL RESEARCH LABORATORYLouise Mawer, Mirabilitas and Lucy Saunderson, Headway Quality Evolution

GOOD LABORATORY PRACTICE

09.00 REMOTE PRECLINICAL AUDIT – IS IT RIGHT FOR ME?Paul Davidson, Headway Quality Evolution 
10.00 SPONSOR OVERSIGHT OF GLP THIRD PARTIESMichelle Manton, Penman Consulting 

10.30 Networking break 

11.00 RESPONDING TO AUDIT REPORTSSven Buckingham, Buckingham QA Consultancy and Peter Connaughton, AstraZeneca

12.30 Networking break and lunch

14.00 LABORATORY STANDARDS: TESTING IN A PANDEMICLouise Handy, Handy Consulting Ltd
14.30 OECD DATA INTEGRITY, Stephen Vinter, MHRA
15.00 GCLP: A HYBRID OF GLP AND GCPMark Goodwin, GSK

15.30 Networking break

16.00 AUDITING SOFT SKILLS INTERVIEW TECHNIQUESLesley Graham, AstraZeneca
17.00 WHAT IS A DEVIATION?…DEEP THOUGHTS Josee-Ann Dulude, CRL and Stephanie Rene, CRL

17.30 QUIZ

INDUSTRY INSIGHTS

18.30 'FORGETTING QUALITY AS YOU KNOW IT' THE ROAD TO QUALITY BY DESIGN, William Lawton, Risk Based Approach Ltd
19.00 MANAGEMENT OF A VIRTUAL QUALITY PROGRAMMEDawn Speidel, Latham Biopharm Group
19.30 BUILDING A CULTURE IN YOUR ORGANISATION TO SUSTAIN DIJoe Franchetti, JAF Consulting, Inc


STREAM THREE:

INDUSTRY INSIGHTS

7.30 GXPS IN THE ADVANCED THERAPY MEDICINAL PRODUCT (ATMP) WORLDMarc Kamp and Eveline Krijger

PHARMACOVIGILANCE

09.00 LESSONS LEARNED FROM MANAGING REMOTE INSPECTIONSDavid Lewis, Novartis
09.30 UPDATE ON EU MEDICAL DEVICES – IMPACT ON PHARMACOVIGILANCE, Aya Souka, GSK
10.00 INSPECTIONS OF NON-INTERVENTIONAL POST-AUTHORISATION SAFETY STUDIESKiernan Trevett, MHRA

10.30 Networking break 

11.00 LICENSING PARTNER RISK ASSESSMENT – WHERE TO NOW? Andrew Cooper, GSK
11.30 REMOTE AUDITINGWumi McDowall, Seqirus
12.00 MARKETING PARTNER PV AUDIT OPTIMISATIONJonathan Rowell, Janssen Pharmaceutical Companies

12.30 Networking break and lunch

14.00 PV AUTOMATION (TRANSCELERATE)Raymond Kassekert, GSK
14.30 PV AUTOMATION, Paul Houri, J&J
15.00 WHAT IS THE FUTURE OF QA? Daniel Dodwell, Roche

15.30 Networking break

16.00 PHARMACOVIGILANCE QA CLINIC, Helen Powell, HYP Pharma Ltd and Allison Jack, GSK

17.30 QUIZ



 

THURSDAY 12TH NOVEMBER

STREAM ONE:

INDUSTRY INSIGHTS

08.00 REMOTE AUDITING: A NEW NORMAL? CHALLENGES AND OPPORTUNITIES Marie-Dominique Mompas, VIGLYA S.L.
08.30 TOP OF THE COVID POPSLouise Mawer, Mirabilitas and Mark Poulton, Poulton Quality Solutions
09.00 THINKING CRITICALLY ABOUT CRITICAL THINKINGCoree Forman, Q-STAR Consulting
09.30 KEY TRAINING: THE RECIPE FOR EFFECTIVE, EFFICIENT AND ENGAGING COMPLIANCE TRAININGErwin de Beuckelaer, Johnson & Johnson
10.00 OPERATIONALISING THE ICH E6 R2 REQUIREMENTS OF QTLsDagmar Goertz, Janssen-Cilag GmbH

10.30 Networking break

11.00 THE JOURNEY OF AN AUDIT FINDING, USING DATA ANALYTICS TO GO FROM SITE TO INSIGHTJoanne North, Janssen
11.30 INSPECTION  READINESS FOR SPONSORS/CROS USING VENDOR SOFTWAREAlan Yeomans, Viedoc Technologies (formerly PCG Solutions)
12.00 THE QUALITY AND COMPLIANCE BENEFITS TO ECONSENTHannah Glenny, Otsuka Pharmaceutical Development & Commercialisation, Inc

12.30 Networking break and lunch

STREAM TWO:

INDUSTRY INSIGHTS

07.30 THE DUTCH COVID APPBrenno de Winter, De Winter Information Solutions and Hans de Raad, OpenNovations
09.00 THE IMPORTANCE OF QUALITY CULTURE IN CLINICAL TRIALSHanna Preus, Opiant Pharmaceuticals
09.30 TRUST AND TRANSPARENCY - A PERSPECTIVE FROM SOFTWARE-AS-A-SERVICE PROVIDERTony Hewer, Medidata Solutions Inc
10.00 FACILITATING GCP COMPLIANCE IN PHASE 1 UNITS: THE ITALIAN CASEAntonella Ursini, seQure

10.30 Networking break

11.00 QA INNOVATIVE APPROACHES DURING COVID19Katie Whigham and Jolanda Bruggencate
11.30 ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPS): FINDING OUR WAY!Christine Mitchell, ChrisalisQAdvice
12.00 REMOTE AUDITS IN PHARMACOVIGILENCE WITH OPTIMUM AUGMENTED INTELLIGENCEGauravkumar Shah, APCER Life Sciences

12.30 Networking break and lunch

STREAM THREE:

INDUSTRY INSIGHTS

07.30 ESTABLISHING A FUTURE PROOFED PLATFORM FOR PROACTIVE QUALITY MANAGEMENT, Gary Chambers, SGS, Ulrich Markens, SGS

GMP

08.30 MODERNISING PHARMA MANUFACTURING WITH DIGITAL QUALITY MANAGEMENT, Robert Gaertner, Veeva Vault Quality
09.00 GMP LEGISLATIVE UPDATEPhil Butson, GSK
09.30 GMP QA CLINIC

10.30 Networking break

GLP

11.00 GLP QA CLINICMark Goodwin, Peter Connaughton, Lisa Heely, Paul Davidson, Vicky Massie and Cate Ovington

12.30 Networking break and lunch

20/20 VISION - A NEW FRONTIER?

14.00 OFFICE BASED INSPECTION STRATEGY, Paula Walker, MHRA and Naoki Tsutsumi, The University of Tokyo

15.00 Networking break

15.30 REGULATORS/EXPERTS/LEADERS ROUNDTABLE, Andrew Gray, MHRA, Ann Meeker O'Connell, Vertex Pharmaceuticals, Theresa Haughey, GSK, Rebecca Stanbrook, Novartis, Marian Mutch, Covance, Peter Connaughton, AstraZeneca
17.30 CLOSE CONFERENCETim Stiles, RQA Chair

 

 

 

Kriss Akabusi

Kriss Akabusi MBE is a three-time Olympic medallist, World, European and Commonwealth Champion, British record holder and media personality. Kriss is a wonderfully entertaining and engaging speaker, ideal for keynotes and award ceremonies. His presentations are high energy, inspiring, and will leave delegates feeling motivated.

Kriss rose to fame on the athletics track, where his greatest individual moment came when he won the gold at the 1990 European Championships; breaking the British record, a record which still stands to this day. Since then, he has gone on to become a household name and one of Britain’s most well-known athletes.

Kriss began his international athletic career in 1983 as a member of the 4 x 400 metre relay squad. In addition to his Gold Medal in the 1990 European Championships, Kriss will always be remembered for helping Britain clinch the Gold and beating the Americans in the World Championships 4 x 400 metre relay in Tokyo in 1991. 

In 1992 as 3-time Olympic medallist and World, European and Commonwealth Champion, Kriss was awarded an MBE by Her Majesty The Queen in recognition of his services to the country through athletics.

Since his stellar athletics career, Kriss has gone on to have a very successful television and media career and is regularly consulted on a variety of radio and television programmes, discussing topics such as sport, business, and personal and professional development.

Kriss Akabusi MBE is also an accredited personal coach, having qualified at the Hudson Institute of Santa Barbara, and is a certified Motivational Maps and Clarity 4D practitioner. These tools are intricately woven into his presentations and workshops. Kriss gained his Post Graduate Diploma in business admin and management (2012-14) at Ashridge business school as he audited the MBA program alongside heads of department of FTSE 500 companies, and he is also currently undertaking his Masters in existential coaching.

For over twenty-five years, The Akabusi Company has provided high-energy, inspirational speeches, workshops, and coaching for businesses and events across the UK.

Kriss’ inspirational story is legendary and works well at the start of a conference to fire up the delegates or as an endnote, leaving the audience on a high and ready to deliver success in their arena. Event attendees will be inspired to be the best they can be both personally and professionally through various points Kriss makes. Topics include how to manage transitions proactively, setting a vision, focusing on goal setting for teams and individuals, identifying and overcoming hurdles, and using innovation to achieve outstanding results.

An experienced and professional celebrity and sporting speaker, Kriss’ humour, energy and infectious enthusiasm ensures that the messages hit home and motivate the audience.

QUALITY ASSURANCE SYSTEMS IN RUSSIA

Review and experience of working with russian clinical trial sites, principal investigators and CRO's including during pandemia period.

Maria Flerova

Since 2016 she has been working as a Senior clinical trials manager of medical department of LLC STPF POLYSAN, a big Russian pharmaceutical company. Key responsibilities – quality assurance, conducting of audits, SOPs writing, cooperation with CROs. Since 2011 had an experience of working in different global and local clinical research companies e.g. Quintiles, MDP-group etc. on positions of a clinical trial coordinator, regulatory manager, quality assurance manager. Maria has a pharmaceutical degree (2011, St. Petersburg State Chemical Pharmaceutical Academy).

THINKING CRITICALLY ABOUT CRITICAL THINKING

 

Beyond technical knowledge to soft skills. What it means to think critically - about risk, about results, and about getting the most out of your teams, projects and products.

Coree Forman

Coree is an accomplished quality management professional with over 15 years’ experience in clinical and pharmacovigilance quality management, quality systems, computer systems, operations and project management, having worked in and with CROs, biotechs, and pharmaceutical companies. In 2018, Coree founded Q-STAR Consulting, a QA consultancy which supports its clients to identify fit-for-purpose solutions to their unique challenges.

KEY TRAINING: THE RECIPE FOR EFFECTIVE, EFFICIENT AND ENGAGING COMPLIANCE TRAINING

Impact of Social Distancing rules and Health care priorities 

Are you ready to challenge the dominant beliefs around compliance training within Quality & Compliance or Learning & Development? Join this session and see how J&J innovates in this space.

Erwin De beuckelaer

Erwin De beuckelaer works at Janssen Pharmaceuticals (J&J) as Director Innovative Capabilities. He brings innovation to the space of Quality & Compliance. Erwin’s mission is to make complicated things as simple as possible, while thoroughly understanding the complexities of today’s business challenges. He is an advocate for human-centered design and design thinking. His background is in communication and user experience design.

BUILDING A CULTURE IN YOUR ORGANISATION TO SUSTAIN DI

 

 

OPERATIONALISING THE ICH E6 R2 REQUIREMENTS OF QTLs

 

While ICH E6 R2 refers to a requirement for establishment of QTLs, there was a need for greater clarity and guidance on how to interpret and operationalise this concept.

QUALITY IN RESEARCH: A FIT FOR PURPOSE APPROACH

 
  • Why quality in research counts?
  • What is the right quality level for the diverse research activities?
  • How can a quality management system for research be established and maintain? 

Alessandra Grande

Alessandra started her QA career in 2004 as Junior GxP QA Auditor. In 2007 she was promoted to Site Quality Auditing Team Head. From 2009 to 2015 she was the Head of QA of Merck Ivrea Test Facility.

Since 2016 she has been Quality Strategy Lead for Translational Medicine, Devices and Research within Merck R&D Quality, being in charge of developing and implementing the quality strategy to support the business. Alessandra is responsible to address quality improvements, define audit entities, interpretate new guidelines, support inspection readiness and deliver training on quality aspects for Good Research Practice, GCP for labs and MD/IVD/CDx.

In 2001 Alessandra degreed in Chemistry and Pharmaceutical Technologies at Turin University and in 2002 she qualified as Pharmacist. She took her MSc from Cranfield University in “Quality Management in Scientific Research and Development“ in 2011. Since 2012 she is qualified as GMP European Qualified Person. She is a QMS Auditor/Lead Auditor ISO 9001:2008 BSI.

LABORATORY STANDARDS: TESTING IN A PANDEMIC

 
  • What standards are applicable for laboratory testing? Differences between clinical trials, diagnostics and other research
  • What standards were defined for testing for COVID-19 in the UK?
  • Assuring quality or targeting quantity?
  • Data integrity and government reporting

Louise Handy

Louise is Director of Handy Consulting Ltd, a long-established independent consultancy providing consultancy, training and Quality Assurance services worldwide for clinical research, laboratory, pharmacovigilance and quality management matters within the pharmaceutical development and Life Sciences research sector.

Louise is a Past Chairman of RQA, is a Fellow of the Association, received the RQA Award, and was Chair of, and remains on, the Good Pharmacovigilance Practice Committee. She has authored and presented extensively, co-authored the Quality Systems Workbook, Quality in Research and Guidelines for Quality in Non-Regulated Scientific Research, provides many courses internationally, and helped develop the MSc in Quality Management in Scientific Research.

WHO’S ON FIRST: DEVELOPING THE BEST INSPECTION TEAM

 

Discussions regarding how to:

  • Understand the roles and responsibilities of the different inspection team members
  • Think critically to identify key inspection team members
  • Propagate a confident inspection readiness culture

Kara Harrison

Kara is an experienced Clinical Research Professional with over 25 years’ experience in Clinical Research, QA, and Regulatory Compliance. Kara started her career as a Field Investigator with the US Food and Drug Administration, concentrating in BIMO programme audits and inspections. Since leaving the agency she has had the opportunity to administer an IRB, and work in academia, big and small pharma, big and small CROs, and consulting. She has experience in most therapeutic areas for both drug and devices and the majority of audit types, including pharmacovigilance. In addition to having conducted hundreds of sites, vendor, CRO, IRB, and laboratory audits; her areas of specialty include Agency inspection facilitation, Mock inspections, Inspection-readiness assessments and training, and quality issue investigations.

TRUST AND TRANSPARENCY - A PERSPECTIVE FROM SOFTWARE-AS-A-SERVICE PROVIDER

 

With increasing multi-player complexity, clarity of roles, responsibilities and deliverables is essential in navigating the data and history of the clinical research world. We discuss and promote the concepts of information transparency, trust between parties and illustrate examples of how this can work.

DUE DILIGENCE IN VENDOR SELECTION

 

Using risk-based methods to select a vendor is required by regulatory health authorities. This rapid-fire talk will highlight due diligence practices and tools available.

Chris Rush

Chris is the President and Owner of FDA Quality and Regulatory Consultants LLC, a global Quality and Regulatory consultancy firm. As a former FDA investigator, Chris inspected both Pharmaceutical and Medical Device manufacturing, laboratories and clinical facilities. As a member of the International Inspection Cadre, Chris participated in multiple FDA inspections in Turkey, Bulgaria and Germany. His inspections led to several regulatory actions taken by the Agency.

Chris’ experience includes employment with global Pharmaceutical and Medical Device companies and provides expertise as a member of several Executive Leadership teams as a Quality Representative. His experience includes providing quality assurance oversight to executive teams, conducting global GxP audits, and authoring pre-notification submission.

Chris founded FDAQRC in 2009 on the principles of communication, integrity and collaboration. He oversees a staff of 14 US home-based employees located across four time zones. FDAQRC has a global network of more than 400 consultants ready to be assigned to client projects.

 

OPPORTUNITIES AND CHALLENGES TO CONDUCTING REMOTE VISITS

 

Delivering truly patient centric clinical trial visits using a range of approaches, best practices and potential problems.

Juliet Hulse

Juliet joined Illingworth Research Group in 2011 as a Senior Research Nurse and after several promotions was appointed to her current the position in 2020 . Juliet has over 20 years’ experience within clinical research, commencing her career in cardiology research covering multiple Phase I- IV trials. Juliet more recently specialised in neurology research, in particular, the field of multiple sclerosis. She has wide experience in the management of trial projects from initiation to close out as well as working with site investigators to improve patient recruitment and patient retention to the study protocols. She believes developing a strategy that places the patient in the centre of the trial is vital for a successful study.

AUDITING TECHNIQUES FOR CAUSE/DIRECTED AUDITS

 

This session will highlight the different techniques used in for-cause or directed audit scenarios such as: when and how to communicate, interview skills, time management and reporting. Several real-world scenarios will be reviewed and interview skills demonstrated.

Tammy Lesko

Tammy began her career more than 26 years ago in GMP manufacturing and transitioned to the US Food and Drug Administration as a Field Investigator with focus in GMP. At the FDA, she found her niche in GCP with BIMO inspections. After leaving the agency, Tammy’s primary focus has been GCP activities. Her areas of specialty include: For cause audits, inspection readiness activities, Agency Inspection facilitation, and mock inspections. She has provided GCP/Human Subject Protection, audit and inspection training presentations for several employers, clients, industry conferences and the Taiwanese FDA Investigators and Reviewers, upon their request.

Tammy has a BS in Biological Science from Montclair State University. Her career with FDAQRC as a Project Manager began in October 2019.

SPONSOR OVERSIGHT OF GLP THIRD PARTIES

 

A look at the expectations and practicalities of sponsor oversight of GLP studies, from the perspectives of different QA personnel including test facility, test site, sponsor, co-sponsor and consultant 'sponsor'.

Michelle Manton

Michelle has 15 years auditing experience as Test Facility, Test site and Sponsor QA, within the scope of GLP, GCP Lab, HTA and GRP. She has conducted audits throughout Europe, and also US, Canada and China. Her current role as Quality and Vendor Manager at Penman Consulting represents a shift from pharmaceuticals to chemicals (UVCBs), and so she is frantically learning about ECHA and REACH, as well as scrubbing up on basic chemistry! In her spare time she is an English Civil War reenactor with no real knowledge of history, a reluctant marathon training runner and a fan of wine.

OPTIMISING TRIAL DESIGN AND RISK-BASED OVERSIGHT THROUGH QUALITY BY DESIGN

Highlight how Quality by Design can optimise both trial design and trial oversight. Discuss clinical Quality by Design Maturity Model

Ann Meeker-O’Connell

Ann Meeker-O’Connell serves as VP, Integrated QMS at Vertex. Ann has over twenty years’ experience in biomedical research in government, academic, and industry settings, including leading the Division of GCP Compliance at the US Food & Drug Administration. Ann earned her MS in Pharmacology as an NIH Integrated Toxicology Fellow at Duke University.

ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPS): FINDING OUR WAY!

A focus on the EMA ATMP Life Cycle through:

  • Research and Development
  • Marketing authorisation
  • Post Marketing authorisation.

Christine Mitchell

Christine has provided Quality Assurance regulatory compliance support for over 35 years. She has participated in various OECD GLP expert working groups. She was Senior Director of Regulatory Compliance at Charles River for several years and in 2020 became an independent consultant at ChrisalisQAdvice. Besides GLP, GCP and GMP she has a special focus on ATMPs.

DO ANALYSTS REQUIRE QUALITY ASSURANCE? FROM A GLP PERSPECTIVE

 
  • The goal of the analyst should be accurate and precise analysis and the goal of quality assurance is to assure the compliance during analysis
  • Elements of the quality are: management/organisation, independence and integrity, technical competence, personnel, equipment and calibration, handling of the samples, method of analysis and working procedure, handling of analysis failure and complaint and review
  • Quality assurance should conduct the audit at various stages of the analysis including the facility inspection.

Smit J. Patel

Smit is Manager-QA of Jai Research Foundation, India. He has a post graduate degree in Pharmacy with specialization in Quality Assurance Technique. Smit joined Jai Research Foundation in 2012 as QA Officer and then promoted to Asst. Manger in 2014 and Manager in 2017. He is actively involved in the development of system SOPs, auditing of various studies, GLP training and CSV. Smit is member of SQA and RQA since 2013 and ICSQA since 2017. He has presented posters and delivered presentation in SQA, RQA and JSQA conferences. /div>

WHY IS IT CALLED QMS? THERE WAS NEVER A BETTER TIME FOR A CONTROLLED REASSESS OF YOUR STRATEGIES AND FRAMEWORK (QMS)

 
  • You need a system to be able to lead
  • A system must be managed – change is unavoidable
  • If top quality is fulfilment of requirements, all processes to fulfil them is the QMS.

Willi Ramseier

Willi is currently owner and director of QVRAM GmbH of Basel, Switzerland. As an expert in quality assurance, system validation, risk awareness and management, Ramseier is a reputed trainer, mentor, and Quality Compliance officer. Previously at Hoffman-La Roche, he now consults across Europe, including as a Process-Validation Expert at Synthes-DePuy-Johnston & Johnston Switzerland and as Quality Consultant and CSV advisor and GxP Workshop Trainer for CROs in Cologne and Dresden. He also is a teacher and lead auditor for ISO9001:2015.

HOW TO MAKE SURE THE QUALITY IS AS IT SHOULD BE OR WHERE DOES TRUST COME IN WHEN YOUR NAME IS AT STAKE?

 
  • Where to find definitions and how to decide which are important
  • About silos, requirements and changes
  • Nothing is complex unless you press variety into templates; or about frames and the absolute.

Willi Ramseier

Willi is currently owner and director of QVRAM GmbH of Basel, Switzerland. As an expert in quality assurance, system validation, risk awareness and management, Ramseier is a reputed trainer, mentor, and Quality Compliance officer. Previously at Hoffman-La Roche, he now consults across Europe, including as a Process-Validation Expert at Synthes-DePuy-Johnston & Johnston Switzerland and as Quality Consultant and CSV advisor and GxP Workshop Trainer for CROs in Cologne and Dresden. He also is a teacher and lead auditor for ISO9001:2015.

 

HOW TO WRITE A VALIDATION OR QUALITY ASSURANCE PLAN – TO BE ABLE TO TRUST THE OUTCOME AND SIGN THE REPORT

 

I cannot tell you what to do, that would be ‘one-fits-all’, but I have the experience to explain a process, which provides the assurance and proof needed for the business to run their process safely.

Willi Ramseier

Willi is currently owner and director of QVRAM GmbH of Basel, Switzerland. As an expert in quality assurance, system validation, risk awareness and management, Ramseier is a reputed trainer, mentor, and Quality Compliance officer. Previously at Hoffman-La Roche, he now consults across Europe, including as a Process-Validation Expert at Synthes-DePuy-Johnston & Johnston Switzerland and as Quality Consultant and CSV advisor and GxP Workshop Trainer for CROs in Cologne and Dresden. He also is a teacher and lead auditor for ISO9001:2015.

THE BASIC QUALITY MANAGEMENT SYSTEM FOR PV PROCESSES REQUIRED IN THE EU

 

The quality management system for PV processes required in EU focusing in business continuity, key performance indicators, CAPA management, Human resources & training, Quality documentation, PV Audits and the risk-based approach, Management of the interfaces, PSMF and more

Laurence Richard

Laurence worked over 4 years as Quality Assurance Manager for a manufacturer of medical devices. She then joined a PV services provider company in 2015 as a Quality Auditor & Quality Assurance Director. Since July 2018, she dedicated herself to the development of the auditing activity within Audithem, a consultancy company and the implementation of these audits. She has more than 50 audits to her credit worldwide as the main auditor.

MANAGEMENT OF MULTI SITE STUDIES - CHALLENGES AND SOLUTIONS

 
  • A multi-site study is a study that is performed at multiple test sites
  • The study must have one study plan, one study director and the study must result in a single final report
  • The multi-site study will be successful if all the communication lines and the responsibilities of the personnel are well defined before the start of the study and if there is an open atmosphere for communication within and between the test facility and test site(s).

Labhu Sanghani 

Labhu is Director of Global QA of JRF Global. He has a post graduate degree in Agricultural Chemistry and Soil Science and Doctorate in Chemistry Dr. Labhu joined Jai Research Foundation in 1993 as Soil Analyst and worked as Study Director for Field Studies. Since 1996 he has been associated with GLP QA. Dr. Labhu had undergone various training on GxP quality system, ISO and various auditing techniques. Dr. Labhu actively involved in the development of system SOPs and GLP training at Jai Research Foundation. He is technical assessor for ISO 17025 accreditation. Dr. Labhu is an active member of SQA and RQA since 1996. Dr. Labhu is actively involved in the establishment of Indian Chapter of Society of Quality Assurance (ICSQA), holding a position of Director in ICSQA.

OUTSOURCING OF NON CLINICAL STUDIES:ENSURING QUALITY AND COMPLIANCE FOR CARE, HOUSING AND CONTAINMENT OF BIOLOGICAL TEST SYSTEM

 

The GLP test facility require adequate support facilities and conditions for the care, housing and containment of animals and other biological test systems, to prevent stress and other problems which could affect the test system and hence the quality and reliability of data. The results of safety testing principally depends on the selection, health, handling and containment of test system and quality standards of facility. For non-clinical animal studies, ensuring the quality and compliance of biological test system including its procurement, maintenance, care and use are highly important.

Labhu Sanghani 

Labhu is Director of Global QA of JRF Global. He has a post graduate degree in Agricultural Chemistry and Soil Science and Doctorate in Chemistry Dr. Labhu joined Jai Research Foundation in 1993 as Soil Analyst and worked as Study Director for Field Studies. Since 1996 he has been associated with GLP QA. Dr. Labhu had undergone various training on GxP quality system, ISO and various auditing techniques. Dr. Labhu actively involved in the development of system SOPs and GLP training at Jai Research Foundation. He is technical assessor for ISO 17025 accreditation. Dr. Labhu is an active member of SQA and RQA since 1996. Dr. Labhu is actively involved in the establishment of Indian Chapter of Society of Quality Assurance (ICSQA), holding a position of Director in ICSQA.

REMOTE AUDITS IN PHARMACOVIGILENCE WITH OPTIMUM AUGMENTED INTELLIGENCE

 

For Remote Audits in Pharmacovigilance, we will discuss methodology of:

  • Technology driven remote audits
  • Precision QA, fundamental base of continuous audit
  • Optimum use of CAPA analysis for Audit preparation and report writing.

FACILITATING GCP COMPLIANCE IN PHASE 1 UNITS: THE ITALIAN CASE

 

The presentation presents a case of developing a set of processes for enhancing GCP compliance for new Phase I Units in Italy and describes a cost-effective model that can be applied for the same goal across Europe.

HINDSIGHT: THE IMPORTANCE OF QTLS TO CLINICAL DEVELOPMENT

 

Quality Tolerance Limits (QTLs) were introduced into GCP in 2016, yet the industry has been slow to apply them. The benefits are numerous, and not least in the development of Quality by Design.

William Andrew Lawton

Andy is probably the world leading expert on the implementation of risk management and Quality by Design in clinical development and has provided consultancy in ICH E6 R2, ICH E8 to over 40 company’s  / groups across five continents. Lawton has extensive experience in computing, statistics, data management, RDE/RDC, system design, Risk Based Approach in both CSV and clinical trials.  


Andy has forty-six years experience in the pharmaceutical industry and NHS, and was a Founding Committee Member of ACDM, Member of TransCelerate RBM, QTL, Data Transparency, eSource work streams and also a Member of EFPIA WG on Data Transparency.  His most notable publications, include the paper with Dr. Alistair Ross on GP Audit (which throughout the 80's and 90's this was the most quoted paper in the BMJ), and he won “best author of the year 2015 and 2016” from the DIA, for the TransCelerate papers on SDV and Central Monitoring in the TIRS Journal.

WHO’S ON FIRST: DEVELOPING THE BEST INSPECTION TEAM

Discussions regarding how to:

  • Understand the roles and responsibilities of the different inspection team members
  • Think critically to identify key inspection team members
  • Propagate a confident inspection readiness culture.

METRICS THAT MATTER

 

This session will discuss the opportunities that lie within metrics, as well as the pitfalls.

Michelle Copeland

Michelle is a QA professional with significant GLP and GCP experience for a wide range of clinical and pre-clinical studies. She is a Registered QA Professional in Good Laboratory and Good Clinical Practice (RQAP-GLP and RQAP-GCP). She joined FDA Quality and Regulatory Consultants in 2017 and is currently a Senior Project Manager.

AGILE DEVELOPMENT FOR CLINICAL RESEARCH SYSTEMS

 

Agile computing methods and tools are used in almost all software development today. Alan will address some of the key issues involved when using agile methods and tools for the development of clinical research software

Alan Yeomans

Alan Yeomans has worked with the development of computerised systems for over 35 years as hardware designer, programmer, system architect, project manager and in a number of management roles including CTO and QM.

Alan has been Quality Manager for PCG Solutions since late 2008, where he is responsible for Quality Assurance of their EDC vendor business. From 2008-2014 he was also the Quality Manager for their CRO business before that part of the company was organised as a separate company. Alan has earlier worked as CTO for a Swedish CRO (CDC) and as CTO and QM for an international ePRO provider (Clinitrac).  

Alan graduated with a Bachelor of Engineering (Electronics) from the University of Western Australia in 1980 and studied Control Systems at the Imperial College (London) in 1983. Alan worked at British Aerospace, Space and Communications Division from 1981 to 1984 as a hardware designer on control systems for communications satellites. 

While there he developed the first CPU-board used in control systems on their communications satellites.   After moving to Sweden in 1984 Alan started working with software development, starting with hardware driver routines and moving up through the software architecture to all levels, including user interface software and database software.

Alan has worked with the use of electronic data in clinical research since 2000, and he has worked in the following international groups aimed at promoting the use of electronic data for clinical research:

  • EHRCR Project – EU Team Leader (internal eClinical Forum project)
  • EHR4CR Project – Member of User Scenario Task Team (EU project)
  • eSource Task Group – Technical Stream Team Leader (internal eClinical Forum project)
  • REG - Regulatory Expert Group – Co-chairman (internal eClinical Forum project)
  • NTWG – New Technologies Working Group – Chairman (internal EUCROF work group)
  • eDigital Team - member (internal ACDM group)
Alan is a member of RQA (the Research Quality Association), eCF (the eClinical Forum), EUCROF (the EU CRO Federation) and ACDM (the Association for Clinical Data Management.

 

OFF ROADING REMOTE AUDIT COMMUNICATION AND PLANNING

 

A Quality Assurance Auditor may conduct 20 or more audits in a year. Most audits require some travel which could range from a few hours to a few days. After conducting a risk-assessment, the stakeholders may conclude that a remote audit suits the situation and you can begin planning the audit approach with the auditee.

Erich Zirzow

Erich Zirzow has more than 20 years’ experience working in Clinical Research, Regulatory Affairs, and Quality Assurance. He’s worked as a Research Coordinator, Research Regulatory Specialist, Regulatory Compliance Manager, and Research Program Manager. His Regulatory and Quality Assurance experience includes conducting many internal, compliance, and investigative site audits.

Erich began working with FDAQRC in July 2019 as a Project Manager, after working as a Department Administrator with one of the premier healthcare organisations in Cleveland, Ohio. Erich served as a department representative for the IRB Executive Committees as well as the Center for Clinical Research SOP and Education Committees. These committees were responsible for education, research compliance, and governance of conducting clinical trials. He has conducted clinical trials and provided regulatory oversight in multiple therapeutic areas such as Medical Genetics, Cardiovascular Genetics, Pediatrics, Anesthesia, Oncology, Urology, Nephrology, and Dermatology.

Erich was fortunate to have worked on two of Cleveland Clinic’s largest groundbreaking clinical research studies that explored the genotypes that are responsible for premature coronary artery disease and heart attacks. These studies led to the discovery of the first confirmed gene that contributed to coronary artery disease in humans, the MEF2A gene.

Erich earned his Master’s in Business Administration from West Liberty University, as well as his Bachelor of Science in Business Administration from Franklin University. In his spare time, Erich enjoys coaching basketball, working out, and spending time with his wife and their 3 children, and two dogs.

IMPROVEMENT OF THE INTERNAL AUDIT TASK SELECTION PROCESS - PRIORITY CHECKS USING RISK SCORING TOOLS

 

Internal Audits are conducted in order to guarantee the quality of the research conducted at Asan Medical centre. However, it is not possible to select and carry out projects that are cost-effective and have high risk. We developed and improved a computerised system to prioritise and select high-risk projects, as we have had problems in the MFDS inspection because we could not conduct internal audit efficiently (Development period: 2019.01~2019.10.20/ open date: 2019.10.21)

Sooyeon Yang

Sooyeon, Yang is a senior GCP QA auditor in Asan Medical Center, South Korea. She is interested in the selection of internal audit targets according to priorities and the efficiency of the internal audit process, and is involved in system development and maintenance. She is also an instructor of GCP training and Quality assurance training at various institutions in South Korea. She was in charge of designating and initial setting of the educational institution for “Education of persons conducting clinical trials” corresponding to Korean legal education in Asan Medical Center.

INSPECTION READINESS FOR SPONSORS/CROS USING VENDOR SOFTWARE

 

The regulatory authorities expect to be able to review relevant documentation about the chosen systems used in a clinical trial. This presentation describes aspects to be considered when using a multi-tenanted cloud solution.

Alan Yeomans

Alan Yeomans has worked with the development of computerised systems for over 35 years as hardware designer, programmer, system architect, project manager and in a number of management roles including CTO and QM. Alan has been Quality Manager for PCG Solutions since late 2008, where he is responsible for Quality Assurance of their EDC vendor business. From 2008-2014 he was also the Quality Manager for their CRO business before that part of the company was organised as a separate company. Alan has earlier worked as CTO for a Swedish CRO (CDC) and as CTO and QM for an international ePRO provider (Clinitrac).  

Alan graduated with a Bachelor of Engineering (Electronics) from the University of Western Australia in 1980 and studied Control Systems at the Imperial College (London) in 1983. Alan worked at British Aerospace, Space and Communications Division from 1981 to 1984 as a hardware designer on control systems for communications satellites.  While there he developed the first CPU-board used in control systems on their communications satellites.  

After moving to Sweden in 1984 Alan started working with software development, starting with hardware driver routines and moving up through the software architecture to all levels, including user interface software and database software. Alan has worked with the use of electronic data in clinical research since 2000, and he has worked in the following international groups aimed at promoting the use of electronic data for clinical research: EHRCR Project – EU Team Leader (internal eClinical Forum project) EHR4CR Project – Member of User Scenario Task Team (EU project) eSource Task Group – Technical Stream Team Leader (internal eClinical Forum project) REG - Regulatory Expert Group – Co-chairman (internal eClinical Forum project) NTWG – New Technologies Working Group – Chairman (internal EUCROF work group) eDigital Team - member (internal ACDM group).

Alan is a member of RQA (the Research Quality Association), eCF (the eClinical Forum), EUCROF (the EU CRO Federation) and ACDM (the Association for Clinical Data Management.

THE IMPORTANCE OF QUALITY CULTURE IN CLINICAL TRIALS

 

Quality culture creates work environment where everyone cares about the quality. Establishing and continuously improving quality culture is crucial for meeting regulatory requirements and achieving business objectives.

Hanna Preus

Hanna Preus is a global Quality & Compliance expert with more than 15 years of versatile QMS, Business Strategy and Operational Excellence experience in clinical trials, including establishing quality culture, promoting leadership, conducting audits, and improving process effectiveness across multidisciplinary functions and in all regions and cultures.

HERE AND NOW: VENDOR QUALITY MANAGEMENT

 

Vendor Quality Management is a key factor of the clinical trials success. Quality has to be employed from the vendor selection stage and controlled throughout the vendor relationship lifecycle.

Hanna Preus

Hanna Preus is a global Quality & Compliance expert with more than 15 years of versatile QMS, Business Strategy and Operational Excellence experience in clinical trials, including establishing quality culture, promoting leadership, conducting audits, and improving process effectiveness across multidisciplinary functions and in all regions and cultures.

HOW LONG SHOULD AN EFFECTIVE AUDIT TAKE?

 

With careful and precise planning, an effective audit should only take the estimated time to fulfil an accurately defined, risk-based audit scope and objective.

Christine Henderson 

Chris currently holds the position of Associate Director of Clinical QA for Eisai. She has worked the regulated industry for 20+ years, holding GCP QA Director roles and working as an independent consultant. Chris holds a PhD in chemistry from the University of Warwick and is a former member of the RQA Board, an RQA MSc tutor, former Chair, and current organising group member of the RQA West and Wales Regional Forum.

Marina Freiberga

Marina is a Principal QA Associate within Tower Mains Clinical team and has over 12 years’ experience in the clinical research industry. She is responsible for the conduct of audits of phase I - IV studies and clinical vendors for compliance with Good Clinical Practice (GCP). She is a medical doctor and holds a Social Sciences Master's degree in Company Management. Before joining TMQA in 2016, Marina was a Senior CRA with global Clinical Research Organizations where she had full CRA responsibilities from site evaluation through to site closure and archiving, ensuring that studies were conducted in accordance with the trial protocol, GCP, Standard Operating Procedures SOPs and applicable regulatory requirements.

GCLP: A Hybrid of GLP and GCP

 

‘GCLP’ is a contentious term. Depending on your location (country), your national monitoring authority, your company’s position or your own personal view you will either fully embrace the term or refuse to recognise the term. GCLP of course is not only a term but a standard or quality system for the analysis of samples from clinical trials, however it is not a Regulation. It is acknowledged that GCLP has been ‘adopted’ by the WHO but it is essentially a standard created by industry and hence the contention. Industry identified a gap and filled the gap. Subsequent to the advent of GCLP there is now regulatory guidance on the analysis of samples from clinical trials, for example the EMA Reflection paper. So where does GCLP ‘sit’? This presentation will explore the standard or quality system needed to assure regulators that analysis of clinical samples is in compliance with GCP and that the data produced is valid, reliable and of sound integrity by means of a robust quality system. Call it ‘GCLP’ or not – does it matter?

Mark Goodwin 

Mark Goodwin is Director of UK Laboratory QA at GlaxoSmithKline. Mark is responsible for the GSK UK GLP Quality Assurance programme and the GCP Clinical Laboratory QA programme. He also manages a team of auditors and provides consultancy to the business.

Mark has worked in GLP QA for over 35 years and gained experience at Life Science Research, Smith Kline & French Research and Glaxo.

Mark was a founder member of the RQA GLP Committee and is the current Chairman of the Committee (third term as Chairman). He currently represents RQA at MHRA GLP Consultative Committee meetings and on the OECD GLP Discussion Group. Mark was a stakeholder during development of the MHRA risk based inspection strategy. He was an industry representative at the OECD Consensus Workshop on Multi-site Studies and participated in the 2008 OECD GLP Event at which Monitoring Authorities, Receiving Authorities and Industry presented topics of GLP interest.

WHAT IS A DEVIATION?…DEEP THOUGHTS

 

What really constitutes a deviation from SOP, Protocol, or Regulations? This discussion will challenge the status quo. Let’s dive into what comprises a value-added deviation. How should unforeseen circumstances be documented and/or reported? How can one maintain transparency in the data and report? This session will also discuss encouraging staff engagement through critical thinking, and accountability.

Megan Lawhead

Megan is the Manager, Regulatory Compliance at the Horsham, Charles River Laboratories site, responsible for managing the Quality Programs at Charles River, Horsham and assisting Regulatory Affairs and Compliance Management in implementing the Charles River Compliance Program. Additionally, Megan works with the site management team to assure regulatory compliance and consistency with Charles River procedures.

Megan has 13+ years’ experience within a GLP-regulated environment with Charles River. Her career began at Horsham site in 2007 where she spent four years in the Study Coordination department prior to transferring to the QA department in 2012. She has been in a leadership role at the Horsham site since 2017.

Megan received a Bachelors of Arts degree in Psychology at West Chester University (Pennsylvania) and a Masters of Arts degree in Biopsychology at George Mason University (Virginia). Professional memberships include the Mid-Atlantic chapter of Society of Quality Assurance, the National Society of Quality Assurance, and the SQA GLP Specialty Section. She has supported the organizations through serving on the MARSQA Board of Directors, as a poster author, and podium presenter on numerous occasions.

QUALITY DATA ANALYTICS: GETTING STARTED, OPTIMISING UNDERSTANDING AND CROSS-COMPANY SHARING

 

In this presentation, we will share how QA (Quality Assurance) teams can get started with analytics; what value they can get from applying analytics to QA; and how QA functions from pharmaceutical companies are working together on setting best practices, sharing data and developing common framework for the application of advanced analytics in QA.

Timothe Menard

Timothé Ménard, PharmD has been leading the PD Quality Data Science Team at Roche since January 2018. From simple analytics methods to machine learning, his team is creating and implementing data-driven solutions that help understand, early detect or predict clinical quality issues.

Jennifer Emerson

As a clinical research professional with 19 years’ Pharmaceutical experience, I have worked in Quality Management, Clinical Project Management, Monitoring and Pharmacovigilance. I have a PhD in Epidemiology and am certified as both a Project Management Professional (PMP) and an ISO 9001:2015 Auditor. My current focus is turning our Quality Data Analytics into company insights.

RESPONDING TO AUDIT REPORTS

 
  • Do you get fed up with receiving inadequate responses to audit findings?
  • Have you been embarrassed when trying to justify inadequate responses to external or internal auditors?
  • Propagate a confident inspection readiness culture.

This presentation will steer you through the thought processes behind producing and reviewing responses to audit findings. The aim is to give you some guidance in achieving the perfect audit response by providing examples of both 'how not to do it' as well as 'how to do it'.

Sven Buckingham

My QA career started with Pharmaco LSR in Suffolk from 1990 to 1995. The role included inspecting and auditing pre-clinical safety studies; acting as Deputy Team Leader and Training coordinator. From September 1995 until December 1998 I was employed as the Laboratory and Clinical Quality Manager at the Harefield site of Schering-Plough Animal Health, formerly Mallinckrodt Veterinary. The role included monitoring the GLP compliance of the Harefield site, inspecting contract facilities, monitoring GMP aspects of clinical trials vaccine production and auditing veterinary GCP clinical studies across Europe.

Since December 1998 I have been self employed as a QA consultant. I have worked with a range of companies, providing services in GLP, VICH GCP and ICH GCP related activities. These companies include large multi-national pharmaceutical companies (in both pharmaceuticals and biologics) involved in human health or animal health, smaller human and animal health companies, agrochemical companies and government agencies. Companies have fulfilled the role of either Sponsor or Contract Research Organisation (CRO). I have also been involved in the audits of many CROs on behalf of Sponsor companies – the CROs have been situated both in Europe and North America.

My auditing activities have primarily centred around GLP studies and facilities. The companies involved include analytical laboratories (small and large molecule), large and small animal toxicology facilities, ecotoxicology facilities and agrochemical field trial facilities. This has included acting as QA manager for test facilities and participating in the QA activities related to GLP compliance. I have been responsible for, or involved in, successful implementation of GLP in small test facilities and also in the closure of GLP compliant facilities.

I have also been involved in auditing veterinary clinical studies for a range of Sponsors and CROs since 1995 to date in a range of species, including pigs, cattle, sheep, poultry, fish, horses, dogs and cats. I have also fulfilled the role of Monitor in canine and equine studies. I have audited central laboratories and other laboratories acting in support of VICH and ICH GCP clinical trials.

Life before QA included 8 years as a Royal Naval Officer and 1 year working on a MAFF research vessel.

I have been a member of the RQA Animal and Veterinary Committee (AVPC, formerly AHC) since 1996 and am currently chair of the AVPC. I have presented at a number of RQA seminars, courses and conferences on a range of topics, together with participating in three joint presentations at SQA conferences with the SQA AHSS. I was awarded the Diploma in Research QA (DipRQA) in 1997 and was elected a fellow of RQA in 2014.

 

INTRODUCTION TO BLOCKCHAIN AND AN EARLY LOOK INTO SOME PROMISING USE CASES IN PHARMA

 

BlockChain is a novel technology, which some predict will be a major disruptor to many well established industries. Whilst still in its relative infancy, there are already several promising use cases which the pharma industry are in the midst of investing in. This session will provide a brief introduction to the concepts of BlockChain and review some of the areas where BlockChain could have the biggest impact on clinical research and healthcare.

Scott Askin

Currently working in the area of Regulatory Innovation for Novartis, Scott has nearly 20 years of pharma industry experience from both the CRO world and within Pharma, in roles focusing on Data Management, Data Standards and Digital Innovation. Prior to joining Regulatory Affairs, Scott led several of Novartis’s innovation projects. Since his transition into Regulatory Affairs, Scott continues to advise digital program teams internally and collaborates in several cross-industry initiatives externally.

HERE AND NOW:EXPERIENCE OF OFFICE BASED INSPECTIONS

  • Are face to face inspections a thing of the past?
  • What do office based (remote) inspections feel like?
  • How to effectively manage an office based inspection. 

Anita Hawkins

31 years within Pharma/Biopharma industry with 24 years’ experience in Quality Assurance and Compliance. Currently responsible for managing internal company issue investigations and regulatory inspections (MHRA, EMA and FDA) both on site, and remotely. Have recently completed a remote EMA inspection, involving: 4 inspectors, 2 CROs, Sponsor and a transition asset/study.

IT QA CLINIC

 

The IT QA Clinic will be run by the RQA IT Committee. QA Clinics are live, interactive sessions where delegates put questions to the expert panel and the questions are discussed within the group. These clinics are usually very popular and the interactive element makes it perfect for the virtual environment.

 

GOOD CLINICAL PRACTICE QA CLINIC

 

The GCP QA Clinic will be run by the RQA GCP Committee. QA Clinics are live, interactive sessions where delegates put questions to the expert panel and the questions are discussed within the group. These clinics are usually very popular and the interactive element makes it perfect for the virtual environment.

Patricia Henley

Patricia is the Head of Research Governance and Integrity at the London School of Hygiene and Tropical Medicine where she has responsibility for LSHTM’s quality management system, regulatory compliance, is the Designated Individual under the Human Tissue Act, and is the primary contact for research integrity.  She is an expert in the field of GCP and regularly travels to research sites across the globe to conduct audits and delivery of training

 

PHARMACOVIGILANCE QA CLINIC

 

The Pharmacovigilance QA Clinic will be run by the RQA Pharmacovigilance Committee. QA Clinics are live, interactive sessions where delegates put questions to the expert panel and the questions are discussed within the group. These clinics are usually very popular and the interactive element makes it perfect for the virtual environment.

Helen Powell

Helen Powell has over 30 years’ experience in the pharmaceutical industry with multinational pharmaceutical company, CRO and consultancy sectors.  She is currently a freelance consultant.  Audit expertise includes performing audits and inspection support in GCP and Pharmacovigilance and auditing corporate legal and reputational risks.

GOOD MANUFACTURING PRACTICE QA CLINIC

 

The Good Manufacturing Practice QA Clinic will be run by the RQA Good Manufacturing Practice Committee. QA Clinics are live, interactive sessions where delegates put questions to the expert panel and the questions are discussed within the group. These clinics are usually very popular and the interactive element makes it perfect for the virtual environment.

Philip Butson, GlaxoSmithKline, UK

Phil Butson FRQA is Director, Quality Futures, at GSK, a role that includes regulatory intelligence, cross-industry collaboration and advocacy.  He is a member of the RQA GMP Committee and takes responsibility for the GMP regulatory updates in Quasar.  He is also a member of the EFPIA IMP Quality Working Group.  

Tony Moult

Experienced in the small batch size packaging of IMP within a range of company types from start-up CMO though mid-size BioPharm to the largest Pharma. Held leadership positions in Operations, CTS PM and Quality. Well informed on the EU Clinical Trial Regulation (CTR) and the new GMPs published in December 2017.

GOOD LABORATORY PRACTICE QA CLINIC

 

The Good Laboratory Practice QA Clinic will be run by the RQA Good Laboratory Practice Committee. QA Clinics are live, interactive sessions where delegates put questions to the expert panel and the questions are discussed within the group. These clinics are usually very popular and the interactive element makes it perfect for the virtual environment.

Cate Ovington

With 20 years' in Quality Assurance, Cate has worked in academic research, contract research organisations, and medical devices. As a Principal Associate with Tower Mains, Cate's primary activities include audit, training, and consultancy for non-clinical facilities, academic and clinical laboratories, and vendor audits encompassing GLP, GCP, ISO accreditation, and the development of customised research quality management systems.

 


 

USING BIG DATA TO TAKE QUALITY BEYOND COMPLIANCE

 

Quality processes produce massive amounts of data that typically are underused. The future of quality involves using AI to interpret quality data, taking quality beyond compliance.

Sue Marchant

Sue is the director of product, machine learning (ML) and artificial intelligence (AI), at MasterControl, where she is responsible for infusing the advanced data mining and analytics capabilities afforded by these technologies into MasterControl’s cloud-based product life cycle excellence software for the life sciences. She spearheads initiatives around actionable, predictive insights and optimized efficiency, productivity, and compliance.

THE QUALITY AND COMPLIANCE BENEFITS TO ECONSENT

Review data obtained from eConsent to provide insights into the quality and compliance benefits, including the ability to track all consents, assents and countersignatures. Discuss the ability to ensure participant comprehension through knowledge check scores.

Hannah Glenny

Hannah Glenny is a Manager of Patient Engagement Strategies in the Applied Innovation and Process Improvement team at Otsuka Pharmaceutical. Her most recent work includes leading various transformation initiatives to deliver the next generation of clinical research, while driving improved patient outcomes and operational efficiencies in the clinical trial process. Hannah possesses a Bachelor Science (BS) in Psychology with a concentration in Neuroscience and actively pursuing a Master of Public Health degree.

FUTURE SHOCK: IMPACT ASSESSMENT OF ICH RENOVATION

 

ICH GCP Renovation: Revision of E8 and Renovation of E6. How are these two guidelines interlinked? What will be the impact for stakeholders?

RISK BASED AUDITING - DEVELOPING A QA AUDIT STRATEGY AND EXECUTION PLAN

 

Risk Based Auditing is being used within organisations in some form or fashion. This presentation will touch upon how a risk based strategy for auditing s to be developed and executed. Real life examples, insights from industry and some common practices for executing the strategy will be discussed.

Milind Nadgouda

Milind is a quality and regulatory professional with 22 years of industry experience. He is the Director of Operations at RiverArk Limited; a Quality Consultancy providing services in GxP space. His core areas of specialisation are Risk Strategy; Regulatory Agency Inspection Readiness and Quality Management System GAP analysis.

REMOTE AUDITING

 

A review of the logistics and challenges of facilitating a successful and effective remote audit in terms of; people, trial processes & systems, documents, data, IMP, equipment, laboratories and facilities.

Cathy Dove

Cathy Dove is a Quality & Risk Management Industry expert, providing risk and quality management consultancy along with quality audits to a range of Pharma and Biotech clients. She is an RQA GCP Committee member and RQA Course Tutor, member of the EFGCP Audit Working Party, ISO 9001;2015 lead implementer and PRINCE II certified project manager practitioner working within Clinical Quality Compliance and Risk Management. Cathy has over 25 years Global Pharmaceutical Clinical Research expertise (Phase I-IV) both from Pharma and CRO and is also a Pharmacist. During her career, Cathy has held various global senior leadership positions (including 2 years based in Singapore) responsible for internal audits across all Clinical Research Services, management and follow-up of inspections from all major regulatory inspectorates and sponsor audits. As an independent consultant Cathy continues to support clients with inspection readiness, risk and quality management projects, sponsor oversight and vendor audits, complex system and for cause site audits and bespoke training course. Cathy has been a course tutor for the RQA GCP Auditing Course for over 15 years and is the lead tutor for the Manageable Risk; Focusing on what matters in clinical trials seminar.

SETTING UP BACK OFFICE OPERATION IN INDIA TO SUPPORT GLOBAL CLINICAL TRIALS

 

This presentation shares the experiences of setting up back office support in India, the challenges and opportunities faced, as well as solutions to making this operating model a success.

Marian Mutch

Marian Mutch is the VP Global Quality Office with Covance based in Indiana in the USA. In her 20 year career with the company, she has held leadership positions in QA, IT and Operations, living in the UK, China, USA and India. She is a past chair of the RQA Computing Committee and over the years has presented at numerous international QA conferences.

COVID-19 GXP INSIGHTS/CONCLUSIONS

 

GxP panel discussion to discuss the impact, insights and takeaways from the COVID 19 pandemic.

UPDATE ON EU MEDICAL DEVICES – IMPACT ON PHARMACOVIGILANCE

 
  • Introduction to EU Medical Device Regulations
  • What is the purpose of the new Medical Device Regulations and what are the main changes?
  • Role of the Person Responsible for Regulatory Compliance
  • Impact to PV Processes
  • Impact on PVQA
  • Notified Body Inspections

Aya Souka

Aya Souka is a Senior Pharmacovigilance Quality Assurance (PVQA) Auditor at GlaxoSmithKline (GSK). She has worked in her role in PVQA for 4 years managing different types of audits, local inspections and notified body inspections for medical devices. Aya previously worked in the Case Management Group at GSK for 2.5 years where she gained a good understanding of drug safety and was a subject matter expert in Medical Devices. Prior to joining GSK, Aya worked in clinical pharmacy and is a UK GPhC registered Pharmacist (Mpharm, PGDip).

GMP LEGISLATIVE UPDATE

 

This presentation will cover the proposed and recent new legislation and guidelines impacting GMP for investigational medicinal products. Key points and links to further information will be provided.

Philip Butson

Phil Butson FRQA is Director, Quality Futures, at GSK, a role that includes regulatory intelligence, cross-industry collaboration and advocacy. He is a member of the RQA GMP Committee and takes responsibility for the GMP regulatory updates in Quasar. He is also a member of the EFPIA IMP Quality Working Group.

CSA CRITICAL THINKING

 

Computer Software Assurance (CSA), a new approach to software quality, is being hotly discussed in the industry. Is CSA really an innovation or just an “agile” application of GAMP5® principles?

AI: VALIDATING COMPUTER SYSTEMS WITH A MIND OF THEIR OWN

 

Addressing the challenges of maintaining regulatory compliance in a rapidly evolving computerised systems landscape.

FUNDAMENTAL CONSIDERATIONS IN THE RESEARCH AND CLINICAL RESEARCH LABORATORY

 

In this session we’ll present fundamental points to consider for the quality management system of the research laboratory. We’ll consider essential elements when crossing over from research to the development GXP-regulated environment, using case examples we’ll target key points of consideration.

  • Research Codes of Practice
  • Aligning Research Principles and the EMA Laboratory Reflection Paper
  • GCP Training for Laboratory Staff 
  • Patient Consent 
  • Data Integrity 
  • Method Validation 
  • Record keeping and archiving.

Louise Mawer

Louise is an independent auditor and trainer for Mirabilitas Ltd (www.mirabilitas.com). She is responsible for audits and training in the disciplines of Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP). A former MHRA GCP and GLP Inspector, Louise established her own company in 2013. She conducts audits, mock inspections and training for Clients in the pharmaceutical industry (including biotech companies) and the non-commercial sector.

Louise has an Honours degree from the Open University, a Diploma in Research Quality and a HND in Science (Medicinal & Cosmetic Products) from Leicester Polytechnic – yes, she’s that old!

Louise is Chair of the EFGCP Audit Working Party, a member of the RQA Northern Regional Forum, and a member of the RQA Research Practice Group.

Louise loves her husband, but also her local baker – he makes cake, good cake, very good cake in fact. Oh and she’s quite a fan of Harry Potter – did she ever mention it?

Lucy Saunderson

Lucy is a Quality Consultant with Headway Quality Evolution (www.headwayqualityevolution.com) and Head of QA at the University of Aberdeen GLP Test Facility, where she is responsible for the development and management of the GLP and GCP audit programme.

PV AUTOMATION (TRANSCELERATE)

 

The Transcelerate Intelligent Automation Opportunities (IAO) has developed a number of deliverables aimed at helping companies who wish to apply automation to their PV activities.

TOP OF THE COVID POPS

Highlights from EFGCP Audit Working Party Clinical Trial webinars during the pandemic:

  • Country guidelines
  • Remote Audits
  • Risk Assessments
  • Deviation Management
  • Ethics during the pandemic
  • Safety Surveillance
  • CSRs and Data Integrity.

Louise Mawer

Louise is an independent auditor and trainer for Mirabilitas Ltd (www.mirabilitas.com). She is responsible for audits and training in the disciplines of Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP). A former MHRA GCP and GLP Inspector, Louise established her own company in 2013. She conducts audits, mock inspections and training for Clients in the pharmaceutical industry (including biotech companies) and the non-commercial sector.

Louise has an Honours degree from the Open University, a Diploma in Research Quality and a HND in Science (Medicinal & Cosmetic Products) from Leicester Polytechnic – yes, she’s that old!

Louise is Chair of the EFGCP Audit Working Party, a member of the RQA Northern Regional Forum, and a member of the RQA Research Practice Group.

Louise loves her husband, but also her local baker – he makes cake, good cake, very good cake in fact. Oh and she’s quite a fan of Harry Potter – did she ever mention it?

Mark Poulton

Mark started his career in Pharmaceutical Discovery Research where he spent 17 years in a number of anti-infective programmes. Mark then moved into Clinical Research where he worked as a global Programme Manager working for a number of different pharmaceutical companies (British, French, American and Japanese) and has managed different trials in many therapeutic areas on a global basis. In this time Mark was involved in all aspects of research from drug development planning, management and reporting of trials and submitting trial data to authorities.

After 13 years in clinical research Mark moved to the MHRA, where he was a GCP Inspector and was involved in all aspects of GCP inspection in the UK and overseas. He was involved in the non-Commercial inspection process and also the bioequivalence inspection process. After 5 years as an inspector, Mark joined ADAMAS Consulting in October 2011 where he was involved in a number of different audit types in different areas of the world, having performed most aspects of GCP, laboratory aspects of GLP and IMP manufacturing aspects of GMP audits. In 2017, Mark moved back into the pharma industry by taking on the Senior Manager QA role at Clovis Oncology and in 2019 set up his own quality consultancy company Poulton Quality Solutions Ltd to provide global quality expertise and advice to clients to ensure compliance and understanding of clinical requirements.

Mark has a degree in Applied Biology, specialising in Microbiology and is a member of Research Quality Assurance (RQA).

LESSONS LEARNED FROM MANAGING REMOTE INSPECTIONS

 

Ahead of you is a remote Supervisory Authority inspection focusing on Good Pharmacovigilance Practices. This is the new normal with COVID-19; how can you best prepare for a successful outcome?

David Lewis

Dave joined Novartis in March 2007 following 20 years' pharmacovigilance at GSK and at Shire. He was EU QPPV at Novartis Pharma AG from April 2009 then Global Head of Pharmacovigilance Systems and Data Management and was appointed Global Head of Pharmacovigilance in February 2011. Dave has worked in country affiliates and in a variety of global safety and risk management functions with both investigational and marketed products, as well as in roles involving systems and processes. Dave is author of papers on the safety of medicines as well as research papers on neuropharmacology. He is senior visiting research fellow, Faculty of Pharmacy, Pharmacology and Postgraduate Medicine, University of Hertfordshire, Project Coordinator for the IMI WEB-RADAR 2 consortium and work package co-leader for IMI ConcePTION.

REMOTE PHARMACOVIGILANCE AUDITS

 

 

  • Introduction
  • Audit announcement and preparation of audit documentation
  • Preparation of the audit
  • Technical preparation and Communication
  • Benefits of remote auditing
  • Drawbacks to remote auditing
  • Points to consider from auditee and auditor perspectives

INDUSTRY 4.0 AND THE TOTAL COST OF QUALITY: THE BI-MODAL CHALLENGE FACING OUR INDUSTRY TODAY

 
  • Meeting the needs and sophistication of today’s life science industry
  • Managing the opposing dynamics of lowering costs whilst enabling innovation
  • Gaining key insight for your organisation that will deliver the superior performance your patients are relying on
  • Embracing digital transformation to ensure product quality, safety, efficacy, continuity of supply and compliance.

Stephen McCarthy

Steve McCarthy is Vice President of Digital Innovation at Sparta Systems. Steve provides domain expertise and serves as an industry evangelist and customer advocate for Sparta. In this role, Steve works closely with Sparta’s customers to help them define and execute their quality management and digital transformations. He heads Spata’s strategic thought-leadership and customer coalition programs, partnering with industry, regulators and analysts to shape the fast-approaching future of quality management systems for life-sciences in service of the health and wellness of the global population. Steve has nearly three decades of experience as a quality and supply chain leader within the healthcare industry. Prior to joining Sparta, he held several high-profile positions within Johnson & Johnson, the most recent of which was as VP of Quality Systems Shared Services for their Pharmaceuticals, Medical Devices and Consumer sectors. There he implemented several complex quality system and process transformations across the enterprise. His earlier career was spent in virology research at the University Hospital St. Thomas’ in London. Steve holds a BSc in Medical & Industrial Biology from Cardiff University in Wales, UK. He is a certified six-sigma process excellence black-belt as well as a certified 3rd degree black-belt karate instructor.

AI: VALIDATION CHANGES

 

Validation of AI solutions requires tuning of validation approach.

Renato Panza

Renato is a senior quality and compliance professional with extensive experience in validation, compliance, IT infrastructure qualification, computer systems validation and implementation of a quality management system within regulated environments gained in the over 15 years’ experience with major pharmaceutical companies. Mr. Panza is working for Roche as Head System Support & Compliance for the Small Molecules department. Till recently he worked for Novartis as Global eCompliance and Digital Lead where he managed a portfolio of technology initiatives and projects for personalized medicines, mature business areas and digital solutions across several IT divisions ranging from development, manufacturing to commercial. He recently implemented a risk based CSV approach for Novartis to enhance effective quality oversight over GxP computerized systems within the IT delivery functions including digital technologies in alignment with quality and regulatory requirements. Member of the Steering Committee of the GAMP Forum UK.

QA OF THE FUTURE: INDUSTRY THINKTANK OUTCOME

 

We plan to share QA of the Future ThinkTank outcome from the EY Quality & Compliance roundtable. We have over 25 companies that actively collaborate and drive innovation within the Quality arena. Leveraging benchmark and use cases to drive learnings and share leading practices. We will share: 1) Operating Model; 2) People & Capabilities; 3) Processes & Enablers.

Sharmila Sabaratnam

Sharmila Sabaratnam is a Director within the life sciences practice of Ernst & Young LLP. She has over 20 years of experience in the pharmaceutical, biotech, medical device and healthcare leading innovation and global transformation within R&D, safety and GxP Quality. As a pharmacovigilance Thought Lead, Sharmila has helped Top25 and Top100 pharmaceutical companies with benchmark led insights and regulatory innovation. Chair the industry Quality & Compliance round-table and benchmark forum to drive disruptive business models across business partner, R&D digitisation/automation, contracts management and third-party oversight. Transformation experiences across GxP Quality Management, Audits/Inspections, Animal Welfare and Bioethics, leading Pharmacovigilance strategy and operating model designs and Clinical transformation across Top-25 and mid-size pharma globally. Have been an RQA member since 2007.

PROVIDING QUALITY ASSURANCE WITH EVERCHANGING TECHNOLOGY

 
  • Providing Quality Assurance using a Risk-Based Methodology
  • Quality by design approach towards changing landscape in technology
  • Collaborative QA – Build a continuum for Application delivery, testing, validation and documentation teams

Milind Nadgouda

Milind Nadgouda is a quality and regulatory professional with 22 years of industry experience. He is the Director of Operations at RiverArk Limited; a Quality Consultancy providing services in GxP space. His core areas of specialisation are Risk Strategy; Regulatory Agency Inspection Readiness and Quality Management System GAP analysis.

BUSINESS RESILIENCE AND EMBRACING TECHNOLOGY DURING COVID-19 - THE GOOD, THE BAD AND THE UGLY

 

Present data on a spike in the use of technology to continue the business, engage with customers and ensure business as usual to whatever extent possible. Discuss the regulatory exemptions for the use of technology by various agencies. Approach towards qualification and validation of the technology in an expedited manner. Repercussions of short-term strategies adopted by organisations without QA input. How to build quality within IT QA framework for future-proofing it towards better resilience.

AUDITING SOFT SKILLS INTERVIEW TECHNIQUES

 
  • The Importance of setting the scene - Building rapport and showing empathy (our power tool)
  • How to ask the right question at the right time and what to do with the answer
  • Listening styles.

Lesley Graham

Lesley joined the Global R&D QA group at AstraZeneca in March 2019. In addition to undertaking complex audits one of Lesley’s main responsibilities is overseeing the Global Process for Inspections. Prior to joining AstraZeneca Lesley spent almost 17 years working for the MHRA as Lead Senior Inspector. During her time at the MHRA Lesley conducted inspections across several of the GXPs namely GLP, GCP and GMP of contract laboratories and investigational medicinal product sites. Lesley represented the UK at global regulator meetings such as the OECD and the EU GLP working party meetings; Lesley took the lead on the recent OECD GLP publication on Test Item and was part of the UK team leading on Data Integrity at OECD. Lesley was regularly involved in training other inspectors in GLP and GMP Quality Control Laboratories; she did this at both a local UK and Global level. As well as being part of the UK Good Laboratory Practice Monitoring Authority, Lesley was also responsible for setting up the routine programme of inspections of UK GMP contract quality control laboratories.

Lesley spent the very early years of her career working in the quality control labs at a Boots manufacturing facility, then in a research lab at Strathclyde University. After graduating in 1994 as an analytical chemist she joined the pharmaceutical industry. Working initially as an analyst in the quality control laboratory then as a supervisor within manufacturing. Here she was responsible for the manufacture of simple solutions and suspensions used in pre-clinical studies, to the more complex formulated products used in clinical trials through to scale up and production of large phase III, comparator and commercial products. It was during her early time in the pharmaceutical industry Lesley first gained experienced of working to both GLP and GMP.

MARKETING PARTNER PV AUDIT OPTIMISATION

 

Innovation in Marketing Partner audits - a programme of multi-party pharmacovigilance audits with mutual recognition between organisations.

Jonathan Rowell

Jonathan is Director, Pharmacovigilance Audit Strategy, Janssen Pharmaceuticals UK Limited. An experienced quality assurance professional, Jonathan has worked across large and small pharmaceutical organisations and as a Pharmacovigilance Inspector with the Medicines and Healthcare Products Regulatory Agency. He specialises in QA audit strategy and is passionate about innovation for the future Quality Assurance organisation.

MANAGEMENT OF A VIRTUAL QUALITY PROGRAMME

 

Great news! Your novel virus, molecule, (fill in the blank), has investors to take it to the next stage. Now what? What should your Quality Systems look like? Does Quality really matter if the company plans to sell after pre-clinical or Phase 1? The company is completely virtual, so how do you create a Quality culture?

Dawn Speidel

Dawn has extensive experience in ensuring GxP compliance within both the biologic and pharmaceutical industries, with advanced subject matter expertise within Quality Assurance.  As a highly focused Global Quality professional, she is committed to working with development teams to create and maintain the highest possible quality standards.  Ms. Speidel brings considerable technical expertise in both biologics and small molecules as well as significant experience with GMP compliance consistent with global regulations and industry expectations.

OFFICE BASED INSPECTION STRATEGY

 

Office-Based Audit (OSA) is an audit model utilising ICT to improve the efficiency of auditing and reduce costs. We report the results of OBA verification experiments in GCP audits.

Overview of MHRA inspection strategy to include office based, remote and digital inspection methods, including a hybrid approach implemented during the Covid-19 period and beyond.

REMOTE AUDITING: A NEW NORMAL? CHALLENGES AND OPPORTUNITIES

 
  • Remote auditing is a challenging topic for the pharmaceutical industry
  • Obligations to comply with standards and to deliver high quality are the same as on-site audits
  • Proper planning, documentation sharing through secure platforms, and close communication are key
  • Any opportunities?

CLOUD BENEFITS IN LIFE SCIENCES

 

How to leverage the cloud and utilize the FDA’s new Computer Software Assurance (CSA) approach to generate better business outcomes. Learn best practices and see real results.

Dr David Blewitt

David is the Vice President of Cloud Compliance at USDM Life Sciences. He is an accomplished life science regulatory and IS compliance professional with more than 25 years of experience in the pharmaceutical, medical device, biotech, and blood management industries, specifically in the fields of computer systems validation, risk management, quality assurance, software development, product life cycle management, and compliance roadmap development.

THE MULTICULTURAL AUDITOR

 

Success is achieved by recognising the cultures from which we come and in which we are auditing. This session is designed to promote awareness of issues facing the multi-cultural auditor.

Andrew Waddell

Andrew set up Tower Mains Ltd in 2001. He holds a Doctorate in Pathology and is a Fellow of the Research Quality Association.

Andrew worked as a Research Fellow and Lecturer in the University of Edinburgh Medical school for eight years before becoming the Professional Advisor at the Scottish Council for Health Education. In 1980 he joined Inveresk Research (now Charles River Laboratories) as the Head of Quality, Regulatory Affairs and Training. During this time, he was responsible for the establishment and development of Good Laboratory Practice, Good Clinical Practice and ISO 9001 systems. He was a member of the OECD working party that established the Principles of Good Laboratory Practice and has worked on several Government / Industry groups.

Since 2001 he has been a Director of Tower Mains Ltd responsible for its Quality Assurance services (known as “TMQA”). Andrew has served as a Director and Chairman of the Research Quality Association (RQA), which he joined in 1980. He has lectured and provided training in Quality Management and Audit in Europe, North America, Japan, Australia and Asia.

Andrew is a former Elite FIFA referee and member of the Scottish Football Association's Congress.

PREVALENCE OF A QUALITY CULTURE DRIVING DATA INTEGRITY- A GMP VS GLP PERSPECTIVE

  • Quality Culture implementation within the GLP and GMP regulated industries.
  • Effectiveness of Quality Culture initiatives in overcoming data integrity issues.

Joyce Ko

Joyce is a QA Professional at PMI. Trained as an Analytical Chemist, with over 10 years’ experience in R&D and QA within GLP/GMP environments, in Singapore and abroad. She holds a BSc in Chemistry (National University of Singapore) and an MSc in Quality Management in Scientific R&D (Cranfield University, United Kingdom).

LICENSING PARTNER RISK ASSESSMENT – WHERE TO NOW?

 

The aim of the presentation is to discuss and review licence partner risk assessments and to discuss risk appetite. Questions to discuss - Which types of licence partner business arrangements represent the highest pharmacovigilance risk

REGULATORS/EXPERTS/LEADERS ROUNDTABLE

 

Roundtable discussion amongst experts, regulators and leaders in their field.

ANN MEEKER-O’CONNELL

Ann Meeker-O’Connell serves as VP, Integrated QMS at Vertex. Ann has over twenty years’ experience in biomedical research in government, academic, and industry settings, including leading the Division of GCP Compliance at the US Food & Drug Administration. Ann earned her MS in Pharmacology as an NIH Integrated Toxicology Fellow at Duke University.

Marian Mutch

Marian is the VP Global Quality Office with Covance based in Indiana in the USA. In her 20 year career with the company, she has held leadership positions in QA, IT and Operations, living in the UK, China, USA and India. She is a past chair of the RQA Computing Committee and over the years has presented at numerous international QA conferences.

 

 

THIRD PARTY RISK MANAGEMENT FROM SELECTION TO TERMINATION/RENEWAL

 

Third party risk management.

The Journey of an Audit Finding; From Site to Insight

 

There is great potential for data analytics to create better insights from audit data. Data analytics can be defined as the process of reviewing, cleansing, transforming, modelling and mining data with the goal of discovering information, interpreting data, informing conclusions and supporting decision making. In the context of audit data, this would entail creating analyses to:

The presentation will focus on discussion on some of the data analytics techniques that can be applied to audit data and the resulting insights that can be gleaned.

  • Enhance insights into risk areas, with actionable insights giving opportunities for learning and change
  • Enable more data driven decisions in aspects such audit planning, conduct and consultancy and inspection readiness activities
  • Predict and mitigate audit (and inspection) findings
  • Move from reactive to more proactive decision making.

Joanne North

I joined Jannsen (part of the Johnson and Johnson group of companies) in September 2017, as Data Analytics Team Lead, working in the Metrics, Reporting and Analytics function within BioResearch Quality and Compliance. My team is responsible for the execution of descriptive, predictive and prescriptive analytics on data from audits and inspections of R&D activities.

Previously I worked within the Clinical Quality Assurance department at GlaxoSmithKline R&D, where I set up and managed a Data Analytics function for 2 years. I also have several years’ experience in the conduct and management of audits, investigations and inspections of clinical trial related activities in the Pharmaceuticals, Vaccines and Consumer Healthcare businesses within GlaxoSmithKline R&D.

REMOTE PRECLINICAL AUDIT – IS IT RIGHT FOR ME?

 

This presentation aims to challenge the perception that remote auditing does not work in a preclinical setting and to help you determine whether it may be right for your organisation. Whilst there are undoubtedly limitations to this type of audit, remote auditing may reduce the costs and actually enhance the oversight of preclinical research when appropriately applied.

Paul Davidson

Paul founded Headway Quality Evolution, a quality consultancy firm, in 2013. Since then he has continued to curate a small team of experienced quality professionals offering services across non-regulated research, the GxPs and ISO standards. He has been a member of the RQA GLP committee since 2011 and is a member of two RQA Regional Forum committees. Prior to HeadwayQE, Paul’s entire career had been focussed in academic or commercial research environments, therefore bringing almost two decades of experience of research quality assurance to the session. Remote auditing has been a technique utilised by Paul at HeadwayQE at in increasing frequency for many years; however, the abrupt changes in the industry seen during 2020 as a consequence of the global Covid-19 pandemic has forced the rapid adaptation of his preclinical oversight programmes.

 

  • Can remote auditing really work in a laboratory environment?
  • How might you approach a remote laboratory audit?
  • Could a hybrid approach be a permanent feature of your oversight programme?

OECD Data Integrity

 

Overview of the development of the OECD guidance on data integrity. Adaptation of the UK guidance into an international GLP standard.

 

MHRA Inspections of Non-interventional Post-authorisation Safety Studies

 

A summary of how standalone GPvP inspections of NI-PASS are prioritised, planned and conducted to assess whether safety data from these studies is appropriately collected, managed and reported.

Transforming Quality for 2020 and Beyond

 

What does quality transformation mean and why is it happening in many leading pharma companies right now?

A successful quality transformation can bring many benefits – gaining deeper insights, improving product quality, delivering operational efficiencies, and finally shifting to data-driven quality management.

Join this session to learn how modernising quality will re-define the connection between systems, processes and people, as part of enterprise-wide digital initiatives.

Also, learn how regulated cloud platforms will dramatically change collaboration within the life sciences community.

You will learn about: 

  • Opportunities and challenges of transforming quality management
  • Best practices for driving a successful transformation
  • Cloud-based collaboration models for the life sciences industry.

Modernising Pharma Manufacturing with Digital Quality Management

 

Why has quality & compliance been a bottleneck in manufacturing and why could it become a driving force for modernisation in the future?

Volatile market demands, increasingly complex therapies, and high regulatory scrutiny will continue as the norm. With the imperative to radically simplify processes and gain more operational agility, manufacturing quality has acknowledged that a new paradigm is needed to overcome longstanding inefficiencies.

New digital technologies will enable manufacturing units to embed quality & compliance activities ‘in the flow’ and ultimately accelerate batch review and release processes.

Join this session to learn about:

  • New technologies helping to bridge gaps between manufacturing and quality
  • The intersection between human operators and automated systems
  • The convergence of internal and external manufacturing networks.

QA of the Future in Pharmacovigilance

 

The PV and Quality landscapes are changing rapidly driven by innovative technologies and a changing external Regulatory environment. Quality must respond by driving a "Future-Ready" strategy through innovative transformation.

Deep dive into CoronaMelder, the COVID19 proximity app

 

The Dutch contact tracing app made a false start by trying to select an 'off the shelve' solution under severe time pressure and cutting corners. In no time it was imminent that a working solution had to be created under direct coordination by the government itself. With a sceptical public that views the it trackrecord on governmental IT projects is pretty poor in general that seems like an uphill battle.

 

But what happens if you pick this fight and decide to put quality first? What are the key success factors for survivals and how do you ensure quality. Everything was done in a non conformistic way: sourcing, approach, rules and acquisition of services. The end result: with a kick ass project and a coalition of the willing the top of the hill became within reach ...

 

The usual due diligence process of EU tenders, which have some resemblance to the GxP / GAMP V-model in terms of URS -> FS -> DS upfront and IQ/OQ/PQ on system commissioning, was distributed over multiple smaller work items and performed by a distributed team of collaborating individual domain professionals and agencies.

 

In this session we will reflect on the lessons learned from the initial “appathon” stage of the project, and provide an in-depth evaluation of the development project and its challenges in both technical aspects as the regulatory compliance domain. Although the CoronaMelder app by itself is not considered a medical device as such, there are some key take-aways and eye-openers when looking at this project through the GxP looking glass.

 

The speakers both have multiple decades of hands-on experience in IT security, data integrity, computerized systems development/commissioning and validations. One of the speakers (Brenno de Winter) is the proverbial thorn in one’s side having been awarded Journalist of the year for his coverage on IT security incidents, Brenno has been coordinating the CoronaMelder project for the Ministry of Health, the other speaker (Hans de Raad) has been an insider in both governmental IT projects, tenders and has been involved in (cybersecurity) standardization and compliance governance, as well as having a proven track record as an IT manager for various laboratories and as a quality and compliance consultant for several multinational pharmaceutical companies.

 

During the session, you may Ask Them Anything!

QA Innovative Approaches During Covid 19

 
  • Work organisation, processes, Technical aspects (IT/consumables), paper data
  • Human aspects of this COVID period
  • Video inspection in field trials
  • Training of new (QA) staff, GLP training
  • Hosting remote audit : advantages/disadvantages for QA hosting the audit, planning up front, Be Patient!

 

 

GXP's in the Advanced Therapy Medicinal Product (ATMP) world

 

ATMP's follow the general practices and regulations of drug product development, however there are additional guidelines and regulations that have to be followed on top of these.

In practice, implementation of these current guidelines come with challenges.

During this presentation we will provide the ATMP regulatory framework for GMP and GCP and discuss these challenges.

Eveline Krijger

Eveline has over 20 years of experience in Clinical Research. As an auditor she supported a wide range of GCP audit types and compliance related activities worldwide. Since 2017 she is Director R&D Quality and Compliance at Kite Pharma, a Gilead company, responsible for the global clinical Kite audit program and supporting Health Authority inspections.

Establishing a future proofed platform for proactive quality management

 

SGS is the world’s leading testing, verification and certification company. Learn why and how SGS Life Sciences selected and deployed TrackWise Digital to support their ONEVISION strategy. SGS implemented TrackWise Digital QMS in approximately 3 months for an initial go-live pilot and are now live at 11 sites across 7 countries, including integration to their Lab systems. (Register to find out more about their digital quality journey to date and plans for the future).

Gary Chambers

Gary Chambers, Global Head for Life Sciences at SGS since 2018, leads the business development strategy and growth plan for the integrated network of analytical testing laboratories across North America, Europe and Asia-Pacific. He joined SGS in 2014 as business manager for the biologics characterization and R&D sites across Europe, then in 2016 was appointed as Global Head of Regulatory and Compliance for the life science segment, part of the 1 B+ CHF Agriculture, Food and Life division at SGS.

Gary started his career in life sciences working on the ground-breaking cloning project “Dolly the Sheep”. Since then, he has held senior executive positions in a number of international biopharmaceutical, CRO and MedTech companies, delivering high growth in multi-channel, global markets. With a proven track record in repositioning organizations and financial planning, Gary’s customer-centric approach produces quick and sustainable results within complex working environments. His passion and drive to make a difference through strong communications and relationship building enables him to lead performant teams to achieve critical strategic goals. Commercially focused, Gary specializes in impact-driven financial models, business transformation, and operational management delivering year-on-year growth by managing streamlined teams that operate with agility in culturally diverse regions.

With a solid background in veterinary medicine and supply chain traceability working on the family’s farming business, which includes a wind farm producing green energy, Gary brings to SGS’ Agriculture, Food and Life division a deep knowledge of business transformation, organizational and change processes, as well as dynamism and direction to see projects to conclusion.

 

Here and now: Eliminate Silos, drive global alignment across clinical and quality

 

Clinical Development is one of the most critical elements within the lifecycle of a drug. In the effort to accelerate clinical trials, the industry has made significant investments in technology in order to streamline Clinical Data Management and Operations.

On the other hand, it remains a key imperative to ensure that complex trials are planned, conducted, and reported in accordance with the highest quality standards and GCP guidelines.

Clinical systems and quality systems have traditionally been kept separate from each other, leading to inefficiencies and risks. With modern cloud-based solutions, those silos can be eliminated by connecting clinical quality data and content where needed, whilst ensuring clear ownership and segregation of duties.

Watch how Veeva Vault unifies clinical, quality, document, and training management applications to automate and harmonize processes globally.

Join this session to see:

  • How Vault unifies all quality, content- and training processes into a single unified application.
  • How business processes are streamlined across the organization and specifically between clinical- and quality management.
  • How Vault organises data and process information for continuous improvement and easy consumption.

'Forgetting Quality as you Know it' The Road to Quality by Design

 

Quality methods in the pharmaceutical industry for clinical development have not followed the methods used by the rest on industry. ICH E8 R1 will start to bring us in line with these traditional methods.

Virtual Trials: Future Now

 

What is being done today, and how are trials being brought to the patient? Hybrid Trials are happening now and are evolving fast.

Virtual Trials: Bringing the Trial to the Patient

 

This presentation looks at the decentralised clinical trial (DCT) landscape:

  • Perceived barriers to adoption of DCTs 
  • Work of the ACRO DCT team 
  • Impact of COVID-19 on the clinical trial landscape
  • Particularly enjoyed how interactive the sessions were this year. Great use of the Conference app for polling questions and panel/speaker questions.