RBQM 2023 On-Demand
Day One Sessions
Day Two Sessions
Keynote: The Global Transformation of RBQM - Research Study Findings from a 2023 Survey and Executive Roundtable Discussions
Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development
The ABC’s of ICH E6 (R3): Understanding the Guidance Updates
Speaker: Dave Nickerson, Head of Clinical Quality Management, EMD Serono
Mastering RBQM During the Design & Planning Phases Critical to Quality Factors
Speaker: Jonathan Rowe, Principal – Head of R&D Quality, Operations & Risk Management, ZS Associates
Keynote Panel Discussion: The RBQM Journey…
Panelists: Karen McCarthy Schau, Sr. Director, Clinical Data Management, Vertex / Lesley Lardino, Senior Director, Data Management, Astellas/ Cris McDavid, Director, Clinical Operations, RBQM, Parexel
The Evolution of QTLs in Light of ICH E6(R3) – Recommendations from Industry Experts
Panelists: Marcin Makowski, Head of Centralized Monitoring and Data Analytics at GSK / Linda Sullivan, Senior Fellow, Tufts Center for the Study of Drug Development / Marion Wolfs, Global Head Risk Management and Central Monitoring, Janssen
Understanding the RBQM Process & Documentation Phase Central Monitoring & Risk Based Study Execution
Panelists: Neshad Sharma, Senior Manager, CD&O Support & Enhancement, Process Excellence, Bayer / Scott Litrakis, Executive Director, Clinical Compliance & Risk Management / Brian Barnes, Director, Risk Management Strategy – Process Excellence & Oversight, BioNTech