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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

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TUESDAY 10TH NOVEMBER

PLENARY SESSIONS

09.00 OPENING ADDRESS, Tim Stiles, RQA Chair

OPENING ADDRESS

RQA's Chair opens the conference.

09.15 KEYNOTE SPEAKER, Kriss Akabusi, The Akabusi Company

10.30 Networking Break

11.00 COVID-19 GXP INSIGHTS/CONCLUSIONSDave Nickerson, Richard Crossland, Stuart Pullen, Joanne Donald and Steve Rogers

12.30 Networking Break and Lunch


CONCURRENT STREAMS 

STREAM ONE:

THE FUTURE OF 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, Sharmila 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 SELECTIONMichelle Holbrook, 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, 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 Emmerson, Boehringer-Ingelheim
14.30 AI: VALIDATION CHALLENGESTBC
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 CLINIC

17.30 Networking Event



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

14.00 FUTURE SHOCK: IMPACT ASSESSMENT OF ICH RENOVATIONKerstin Koenig, Merck and Rebecca Stanbrook, Novartis
14.30 FUTURE SHOCK: UK AND THE EU CTR, TBC
15.00 FUTURE SHOCK: VIRTUAL TRIALSTBC

15.30 Networking break

16.00 GOOD CLINICAL PRACTICE QA CLINIC

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


STREAM TWO:

INDUSTRY INSIGHTS

08.00 FUNDAMENTAL CONSIDERATIONS IN THE RESEARCH AND CLINICAL RESEARCH LABORATORYLouise Mawer, Mirabilitas and Lucy Saunderson, Headway Quality Evolution

GOOD LABORATORY PRACTICE

09.00 LABORATORY STANDARDS: TESTING IN A PANDEMICLouise Handy, Handy Consulting Ltd
09.30 GCLP: A HYBRID OF GLP AND GCPMark Goodwin, GSK
10.00 HARMONISING THE RELATIONSHIP BETWEEN TEST FACILITIES AND SPONSORSTBC

10.30 Networking break 

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

12.30 Networking break and lunch

14.00 AUDITING SOFT SKILLS INTERVIEW TECHNIQUESLesley Graham, AstraZeneca
15.00 OECD DATA INTEGRITYAndrew Gray, MHRA

15.30 Networking break

16.00 RESPONDING TO AUDIT REPORTSSven Buckingham, Buckingham QA Consultancy and Peter Connaughton, AstraZeneca
17.00 WHAT IS A DEVIATION?…DEEP THOUGHTSMegan Lawhead, Charles River Laboratories

17.30 QUIZ

INDUSTRY INSIGHTS

18.30 TBC
19.00 MANAGEMENT OF A VIRTUAL QUALITY PROGRAMME
Dawn Speidel, Latham Biopharm Group
19.30 BUILDING A CULTURE IN YOUR ORGANISATION TO SUSTAIN DIJoe Franchetti, JAF Consulting, Inc


STREAM THREE:

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 INTERVENTIONAL STUDIES INSPECTIONSKiernan Trevett, MHRA

10.30 Networking break 

11.00 TBC
11.30 REMOTE AUDITING
Wumi McDowall, Seqirus
12.00 PV AUDITING: INNOVATIVE WAYS OF WORKING IN A CHANGING ENVIRONMENTMagda Daudin, Janssen-Cilag

12.30 Networking break and lunch

14.00 PV AUTOMATION (TRANSCELERATE)Raymond Kassekert, GSK
14.30 PV AUTOMATION, Paul Houri, J&J
15.00 TBC

15.30 Networking break

16.00 PHARMACOVIGILANCE QA CLINIC 

17.30 QUIZ



 

THURSDAY 12TH NOVEMBER

STREAM ONE:

INDUSTRY INSIGHTS

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 FINDINGJoanne 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

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 TBC
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

GMP

09.00 GMP LEGISLATIVE UPDATEPhil Butson, GSK
09.30 GMP QA CLINIC

10.30 Networking break

GLP

11.00 GLP QA CLINIC

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 ROUNDTABLEMHRA plus others
17.30 CLOSE CONFERENCETim Stiles, RQA Chair

 

 

 

Kriss Akabusi

Kriss rose to fame on the athletics track, where his greatest individual triumph was winning the gold medal in the 1990 European Championships. This was the day when he beat David Hemery’s British record for the 400 metre hurdles – a record that stood for 22 years before Kriss made his mark on it!

Kriss began his international athletics career in 1983 as a member of the 4x400 metre relay squad. He will probably always be remembered for helping Britain clinch the gold from the mighty Americans at the 1991 World Championships in Tokyo.

Having amassed three Olympic medals, as well as World, European and Commonwealth titles, Kriss was bestowed with an even greater honour in 1992: an MBE awarded by her Majesty the Queen in recognition of his services to the country through athletics.

Kriss has also made numerous TV appearances and will be presenting live at the RQA International QA Conference this year. 

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.

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.
 

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.

Michelle Holbrook

Michelle has been working in Quality Assurance (QA) for over 15 years and joined FDA Quality and Regulatory Consulting (FDAQRC) in 2015. She completed her Bachelor of Science at North Carolina State University. She has been a Registered Quality Assurance Professional in good clinical practices (RQAP-GCP) and is an active member, holding elected positions, within the Society of Quality Assurance (SQA) and the North Carolina chapter of SQA.

Michelle is a well-respected business leader and QA professional with the experience and capabilities to manage an international team of QA auditing professionals and skills to develop annual audit plans relative to Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Pharmacovigilance (GVP) audits. She began her career in the industry by developing and managing standard practices and processes, qualifying new vendors and training personnel on GCPs at a large scientific organization in North Carolina. She then spent time working in a vigorous site audit department and developing her interpersonal skills.

Her role as a Senior GCP Auditor at a large Contract Research Organisation (CRO) gave her an opportunity to expand her repertoire and included responsibilities for the quality oversight of numerous projects across a variety of indications, conducting a multitude of audits including: contracted audits, systems audits, regional office audits, for-cause audits, and vendor audits; hosting sponsor audits; and implementing Corrective and Preventative Actions in a team environment. She was based out of Australia where she was responsible for the quality management in that CRO’s Asia-Pacific region. She is a qualified professional with wide ranging experience in varying types of GCP, Computerised Systems Practices (CSV) and GxP auditing, training, and consultancy with extensive experience in Standard Operating Procedure (SOP) and Risk-Based planning and decision making gained through increasing positions of responsibility in the pharmaceutical industry. She has a dog, a cat and is an avid horsewoman.

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'.

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.

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.

 

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

Su 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

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

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.

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.

 

  • Particularly enjoyed how interactive the sessions were this year. Great use of the Conference app for polling questions and panel/speaker questions.