EUQA19 Programme

EUQA19 PROGRAMME Wednesday 6th November 2019 PLENARY - AUDITORIUM 09.20 - 09.30 Opening Address, Vanessa Grant, Laurent Bouillot, Steffen Koenig 09.30 - 10.30 Keynote Address, Dr Phil Hammond Networking break, The Forum 11.00 - 11.45 11.45 - 12.30

AI & Machine Learning in Drug Discovery, Lindsay Edwards Applying Advanced Analytics to Quality Assurance, Timothé Ménard

Lunch PV/GCP - AUDITORIUM 13.30 - 14.15 PASS/PAES - Is it Just About Gathering Safety and Efficacy Data?, Wendy Koç 14.15 - 15.00 GCP/PV Aspect of the PSMF, Alison Allen MEDICAL DEVICES - WICKLOW 2B 13.30 - 14.00 Quality in Product Innovations for Start-Ups, SME, and Incumbent Medical Device Manufacturers Through

the New EU Medical Device Regulation, Max Singh 14.00 - 14.30 Mandatory Quality Requirements for Combinations of Drugs and Devices, Henny Koch 14.30 - 15.00 Cybersecurity in Medical Devices, Peter Graham ACADEMIA - WICKLOW 2A 13:30 - 14:00 Quality Criteria for Repositories Hosting Clinical Trial Data, Rita Banzi 14:00 - 14:30 Enhancing High-Quality Data Management Services in European Non-Commercial Clinical Trials, Christine Toneatti 14:30 - 15:00 Archiving of Electronic Data in Clinical Trials, Alan Yeomans ANIMAL HEALTH - WICKLOW MEETING ROOM 1 13.30 - 14.00 Veterinary Investigational Medicinal Products: Exempt or Not-exempt… is that the question?, Marci Murphy 14.00 - 14.30 VICH GCP Studies – An investigator’s perspective, Nick Garvey 14.30 - 15.00 In at the Deep-End: GMP to GCP - auditing in a new discipline, Conor Kerr Networking break, The Forum PV - AUDITORIUM 15.30 - 16.00 An MHRA Perspective on Automation, Machine Learning & Artificial Intelligence, Phil Tregunno 16.00 - 16.30 QP Challenges in relation to Brexit, Liz Hancox 16.30 - 17.00 Inspection of PV IT Systems, Diane Hallé MEDICAL DEVICES - WICKLOW 2B 15.30 - 16.00 The Use of Eye Tracking Technology to Improve interface Design, Hannah Torney 16.00 - 16.30 ISO 14155 Revision Update, Danielle Giroud 16.30 - 17.00 Interactive Clinic Session GDP/GMP - WICKLOW 2A 15.30 - 16.15 Draft Revision of the EU GMP Annex 1: new update and key points, Jean-Francois Beck 16.15 - 17.00 Forging Strong Bases for a Sustainable Transport Partnership in a GDP Environment, Herve Valler ANIMAL HEALTH - WICKLOW MEETING ROOM 1 15.30 - 16.00 Auditing Research Animal Facilities, Helena Paradell 16.00 - 17.00 Animal Health QA Clinic 17.15 Meet the Delegate Drinks Reception, The Forum

Thursday 7th November 2019 GCP - AUDITORIUM 09.00 - 09.45 GCP Renovation – ICH E8 and ICH E6, Fergus Sweeney 09.45 - 10.30 Clinical Quality-by-Design (QbD): Principles to Practice, Ann Meeker-O’Connell COMPUTING/IT - ECOCEM 09.00 - 09.30 Self-Driving Cars Take Ethical Decisions - Let’s Talk About AI in Healthcare, Ingo Baumann 09.30 - 10.00 Leveraging Knowledge Graphs, Data Linking and Semantic Technologies for Quality Assurance, Sören Auer 10.00 - 10.30 Thinking Risk to Determine Strategy, Barry McManus GLP - WICKLOW HALL 2 09.00 - 09.30 OECD Document About Test Item Management: What is New?, Thomas Lucotte

09.30 - 10.00 10.00 - 10:30

Bridging the Gap Between New (and Not so New) Technologies and the Regulations, Sara Ryback Data Pathology: Quality Expectations and Regulatory Requirements to Ensure Data Quality and Data Integrity, Alain Piton

Networking break, The Forum GCP - AUDITORIUM 11.00 - 11.30 Big Data and Artificial Intelligence, From Concept to Care, Ignacio Hernandez Medrano 11.30 - 12.00 Regulatory Perspective on Direct Data Capture by Trial Subjects and Their Social Media Use, Torsten Stemmler 12.00 - 12.30 Auditing Real World Evidence (RWE) / Real World Data (RWD), Mercedes Martinez-Carretero COMPUTING/IT - ECOCEM 11.00 - 11.30 Blockchain and the Next Steps, Matt Jones 11.30 - 12.00 A Story About FIT EDDI and the COMET, Olga Stoll 12.00 - 12.30 Computing/IT QA Clinic GLP - WICKLOW HALL 2 11.00 - 12.30 GLP Workshop Lunch, The Forum GCP - THE AUDITORIUM 13.30 - 14.00 eSource Direct Data Capture and eConsent, Rebecca Stanbrook, Scott Askin 14.00 - 14.30 Audit Trail Review During Audits – Practical Aspects, Aurelie Delaunay 14.30 - 15.00 The Role of Technology in Streamlining Audit, Michael Baptist GLP - WICKLOW HALL 2 13.30 - 14.00 GXP and Cloud Computing, a Marriage Made in Compliance Heaven, or a Classic Film Noir Scenario?, Hans de Raad 14.00 - 14.30 e-Archiving in the Cloud: Strengths and Limitations. Are We in Control?, Ali Bouhuijzen 14.30 - 15.00 Sample Archiving and Biobanking Under GxP Conditions, Benjamin Bader PV - ECOCHEM 13.30 - 14.00 Outsourcing Pharmacovigilance Activities: How to Set it Right, a MAH Perspective, Alina Tudor 14.00 - 14.30 Challenges Faced in Working with Multiple Clients - a Service Provider’s Perspective , Mark Banahan 14.30 - 15.00 Managing PV: How to Future Proof Your Organisation, with the Application of Technology and Innovation, Alison Sloane Networking break, The Forum GCP - THE AUDITORIUM 15.30 - 16.00 Digital Trials of the Future: Quality by Design Best Practices, Bola Oyegunwa 16.00 - 17.00 GCP QA Clinic GLP - WICKLOW HALL 2 15.30 - 17.00 GLP Roundtable, Martijn Baeten, Ronald Bauer, Thomas Lucotte, Ulrich Schepers, Stephen Vinter PV - ECOCEM 15.30 - 16.00 Collecting Safety Data from Commercial Activities, Manjit Virdee 16.00 - 16.30 Inspections Update, Rajbinder Bhogal 16.30 - 17.00 PV QA Clinic 19.00 Pre-dinner Drinks Reception, The Forum 19.30 Dinner Dance, The Forum

Friday 8th November 2019 PLENARY - AUDITORIUM 09.00 - 09.15 09.15 - 10.15

JSQA Update Future of QA in a Changing World, Deborah Driscoll, Ann Meeker-O’Connell, Monika Pietrek, Carla Wandt

Networking break, The Forum 10.45 - 12.00 12.00 - 12.15

Regulators Roundtable, Diane Hallé, Olivier Leblaye, Fergus Sweeney Technology and Innovation in Quality: A Brave New World?, Vanessa Grant, Steffen Koenig, Laurent Bouillot

End of conference