09.00 OPENING ADDRESS: Tim Stiles, RQA Chair

09.10 WELCOME FROM VEEVA, Robert Gaertner, Veeva

09.15 KEYNOTE SPEAKER: Kriss Akabusi, The Akabusi Company

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

13.30 TRANSFORMING QUALITY FOR 2020 AND BEYOND: Robert Gaertner, Veeva SLIDES

14.00 THE MULTICULTURAL AUDITOR: Andrew Waddell, Tower Mains SLIDES

14.30 INDUSTRY 4.0 AND THE TOTAL COST OF QUALITY: Stephen McCarthy, Sparta Systems SLIDES

15.00 QA OF THE FUTURE: INDUSTRY THINKTANK OUTCOME: Sharmila Sabaratnam, Ernst & Young SLIDES

14.00 A SESSION ON CREATING A QA OR VALIDATION PLAN: Willi Ramseier 

14.30 QUALITY IN RESEARCH: A FIT FOR PURPOSE APPROACH: Alessandra Grande, Merck SLIDES

15.00 QUALITY ASSURANCE SYSTEMS IN RUSSIA: Maria Flerova, LLC STPF POLYSAN SLIDES

14.00 QUALITY DATA ANALYTICS: GETTING STARTED, OPTIMISING UNDERSTANDING AND CROSS-COMPANY SHARING: Timothe Menard, F. Hoffmann - La Roche Ltd and Jennifer Emmerson, Boehringer-Ingelheim SLIDES

14.30 AI: VALIDATION CHALLENGES: Renato Panza, Roche SLIDES

15.00 AI: VALIDATING COMPUTER SYSTEMS WITH A MIND OF THEIR OWN: Richard Brown, ADAMAS Consulting SLIDES

16.00 THIRD PARTY RISK MANAGEMENT FROM SELECTION TO TERMINATION/RENEWAL: Oliver Steck, Deloitte & Touche LLP and Chris Rush, FDA Quality + Regulatory Consultants SLIDES

16.30 USING BIG DATA TO TAKE QUALITY BEYOND COMPLIANCE: Sue Marchant, MasterControl Inc. SLIDES

17.00 OPTIMISING TRIAL DESIGN AND RISK-BASED OVERSIGHT THROUGH QUALITY BY DESIGN: Ann Meeker O’Connell, Vertex Pharmaceuticals SLIDES

16.00 RISK BASED AUDITING - DEVELOPING A QA AUDIT STRATEGY AND EXECUTION PLAN: Milind Nadgouda, RiverArk Limited 

16.30 INTRODUCTION TO BLOCKCHAIN AND AN EARLY LOOK INTO SOME PROMISING USE CASES IN PHARMA: Scott Askin, Novartis SLIDES

17.00 SETTING UP BACK OFFICE OPERATION IN INDIA TO SUPPORT GLOBAL CLINICAL TRIALS: Marian Mutch, Covance SLIDES

STREAM 3 - SESSION 4 - IT

16.00 CSA CRITICAL THINKING: Oliver Hermann, QFINITY

16.30 CLOUD BENEFITS IN LIFE SCIENCES: David Blewitt SLIDES

17.00 IT QA CLINIC: Joanne Donald, Roche,  Sarah Pickersgill, Celerion, Keith Thornley, Eli Lilly, Matt Davies, Veeva SLIDES

18.30 WHO’S ON FIRST: DEVELOPING THE BEST INSPECTION TEAM: Kara Harrison, FDA Quality + Regulatory Consultants SLIDES

19.00 DUE DILIGENCE IN VENDOR SELECTION: Chris Rush, FDA Quality + Regulatory Consultants SLIDES

19.30 OFF ROADING REMOTE AUDIT COMMUNICATION AND PLANNING: Erich Zirzow, FDA Quality + Regulatory Consultants SLIDES

20.00 AUDITING TECHNIQUES FOR CAUSE/DIRECTED AUDITS: Tammy Lesko, FDA Quality + Regulatory Consultants SLIDES

20.30 METRICS THAT MATTER: Michelle Copeland FDA Quality + Regulatory Consultants SLIDES

18.30 THE BASIC QUALITY MANAGEMENT SYSTEM FOR PV PROCESSES REQUIRED IN THE EU: Laurence Richard, Audithem SLIDES

19.00 AGILE DEVELOPMENT FOR CLINICAL RESEARCH SYSTEMS: Alan Yeomans, Viedoc Technologies (formerly PCG Solutions) SLIDES

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 TOOLS: Sooyeon Yang, AMC 

07.30 MANAGEMENT OF MULTI SITE STUDIES - CHALLENGES AND SOLUTIONS: Labhu Sanghani, Jai Research Foundation SLIDES

08.00 OUTSOURCING OF NON CLINICAL STUDIES:ENSURING QUALITY AND COMPLIANCE FOR CARE, HOUSING AND CONTAINMENT OF BIOLOGICAL TEST SYSTEM: Labhu Sanghani, Jai Research Foundation SLIDES

08.30 DO ANALYSTS REQUIRE QUALITY ASSURANCE? FROM A GLP PERSPECTIVE: Smit Patel, Jai Research Foundation SLIDES

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 LABORATORY: Louise Mawer, Mirabilitas and Lucy Saunderson, Headway Quality Evolution SLIDES

09.00 HINDSIGHT: THE IMPORTANCE OF QTLS TO CLINICAL DEVELOPMENT: William Lawton, Risk Based Approach Ltd SLIDES

09.30 DATA INTEGRITY: TALES FROM THE INVESTIGATOR SITE: Piran Sucindran, Invicro UK SLIDES

09.00 REMOTE PRECLINICAL AUDIT – IS IT RIGHT FOR ME? Paul Davidson, Headway Quality Evolution SLIDES

10.00 SPONSOR OVERSIGHT OF GLP THIRD PARTIES: Michelle Manton, Penman Consulting 

09.00 LESSONS LEARNED FROM MANAGING REMOTE INSPECTIONS: David Lewis, Novartis SLIDES

09.30 UPDATE ON EU MEDICAL DEVICES – IMPACT ON PHARMACOVIGILANCE: Aya Souka, GSK SLIDES

10.00 INSPECTIONS OF NON-INTERVENTIONAL POST-AUTHORISATION SAFETY STUDIES: Kiernan Trevett, MHRA SLIDES

11.02 HERE AND NOW: REMOTE AUDITING: Cathy Dove, Dove Quality Solutions SLIDES

11.30 HERE AND NOW: VENDOR QUALITY MANAGEMENT: Hanna Preus, Opiant Pharmaceuticals SLIDES

12.00 HERE AND NOW:EXPERIENCE OF OFFICE BASED INSPECTIONS: Anita Hawkins, GSK SLIDES

11.02 REMOTE AUDITING: Wumi McDowall, Seqirus SLIDES

11.30 LICENSING PARTNER RISK ASSESSMENT – WHERE TO NOW? Andrew Cooper, GSK SLIDES

12.00 MARKETING PARTNER PV AUDIT OPTIMISATION: Jonathan Rowell, Janssen Pharmaceutical Companies SLIDES

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 RENOVATION: Kerstin Koenig, Bristol-Myer Squibb and Rebecca Stanbrook, Novartis SLIDES

14.30 VIRTUAL TRIALS - BRINGING THE TRIAL TO THE PATIENT: Fiona Maini, Medidata SLIDES

15.00 VIRTUAL TRIALS - FUTURE NOW: Fatemeh Jami, The Medical Research Network SLIDES

14.00 LABORATORY STANDARDS: TESTING IN A PANDEMIC: Louise Handy, Handy Consulting Ltd SLIDES

14.30 OECD DATA INTEGRITY: Stephen Vinter, MHRA SLIDES

15.00 GCLP: A HYBRID OF GLP AND GCP: Mark Goodwin, GSK 

14.00 PV AUTOMATION (TRANSCELERATE): Raymond Kassekert, GSK SLIDES

14.30 QA OF THE FUTURE IN PHARMACOVIGILANCE: Paul Houri, J&J SLIDES

15.00 WHAT IS THE FUTURE OF QA? Daniel Dodwell, Roche SLIDES

16.00 AUDITING SOFT SKILLS INTERVIEW TECHNIQUES: Lesley Graham, AstraZeneca SLIDES

17.00 OECD21 ADVISORY DOCUMENT ON SPONSOR INFLUENCE ON STUDIES: Josee-Ann Dulude, CRL and Stephanie Rene, CRL 

18.30 OPPORTUNITIES AND CHALLENGES TO CONDUCTING REMOTE VISITS: Juliet Hulse, Illingworth Research Group SLIDES

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 UGLY: Milind Nadgouda and Yogesh Agarwal, RiverArk Ltd

18.30 'FORGETTING QUALITY AS YOU KNOW IT' THE ROAD TO QUALITY BY DESIGN, William Lawton, Risk Based Approach Ltd SLIDES

19.00 MANAGEMENT OF A VIRTUAL QUALITY PROGRAMME: Dawn Speidel, Latham Biopharm Group SLIDES

19.30 BUILDING A CULTURE IN YOUR ORGANISATION TO SUSTAIN DI: Joe Franchetti, JAF Consulting, Inc SLIDES

20.00 FIRESIDE CHAT WITH THE VP OF QUALITY AT MCKESSON, Barry Cook, McKesson