September 6th - 7th, 2023
2023 Agenda
Day One Sessions
Day Two Sessions
08:30 - 09:30 am
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
09:30 - 09:40 am
RBQM Chat Café
09:40 - 10:50 am
The ABC’s of ICH E6 (R3): Understanding the Guidance Updates
Speaker: Dave Nickerson, Head of Clinical Quality Management, EMD Serono
10:50 - 11:00 am
RBQM Chat Café
11:00 am - 12:00 pm
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
08:30 - 09:45 am
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
09:45 - 09:55 am
RBQM Chat Café
09:55 - 11:00 am
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
11:00 - 11:10 am
RBQM Chat Café
11:10 am - 12:00 pm
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, Bristol-Myer Squibb / Brian Barnes, Director, Risk Management Strategy – Process Excellence & Oversight, BioNTech

*All times are in Eastern Standard Time (EST)