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Session 1: Risk-Based Quality Management in Your Organization
Session Chair(s)
Peter Stokman, MSc
Sr Expert Data Manager
Bayer, Netherlands
Ten years ago ICH suggested Risk Based Quality Management as a tool in Clinical Development. This suggestion was picked up by the Transcelerate initiative to improve the quality of site monitoring by leveraging the trove of data that became available in the wake of electronic data capture. Now: what is the role of RBQM in the other areas of clinical development? Can we wait for a technical solution? Why is it needed in the first place? With the adoption of ICH E6 (R2) - the Addendum to CGP - RBQM in Clinical Development is no longer optional; it has to become an integral part of your clinical quality management system. This presentation will zoom in on background and need for RBQM in Clinical Development, and it will give practical suggestions on how to implement RBQM in your processes.
Speaker(s)
Risk-based Quality Management – Philosophy versus Reality
Gunnar Danielsson
Pharma Consulting Group, Sweden
Senior Regulatory Advisor
Risk-based Quality Management of Clinical Trials
Fergus Sweeney, PhD
European Medicines Agency, Netherlands
Head of Clinical Studies and Manufacturing Task Force
Risk-Based Quality Management: TransCelerate’s Support to turn Principles into Practice
Kerstin Koenig, PhD, MSc
Bristol Myers Squibb, United States
Vice President, Research and Development Quality
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