Day 1Wednesday, 2 December 2020

10:25 - 10:305 mins

Co-Chairs Welcome and Opening Remarks

Christopher Biddle - Associate Director, Risk Management and Central Monitoring, Janssen Research

10:30 - 10:5020 mins

Leadership Perspective: Change Management

10:50 - 11:1020 mins

State of the Industry Report

Steve Young - Chief Scientific Officer, CluePoints

11:10 - 11:2010 mins

Take a Break and Visit our Virtual Exhibit Hall!

11:20 - 12:0040 mins

Panel Debate: State of the Industry from Stakeholders

Andy Lawton - Director, Risk-Based Approach Ltd
Rosanne Petros, PMP - Associate Director, Clinical Research, Merck Research Laboratories
Steve Young - Chief Scientific Officer, CluePoints
Esther Huffman O'Keefe - Associate Director, Monitoring, Global Clinical Operations, Regeneron
Stephanie Clark - Director, Risk Management - Central Monitoring, The Janssen Pharmaceutical Companies of Johnson & Johnson

12:00 - 12:2020 mins

Regulatory Review: ICH E8 and ICH E6v3 - How do they Impact RBM and You!

Andy Lawton - Director, Risk-Based Approach Ltd

12:20 - 13:2060 mins

Grab Some Lunch then Come Back to Join in Networking Activities, Watch Product Showcases, and Connect with Your Key Product and Service Providers in the Virtual Exhibit Hall!

13:20 - 13:4020 mins

Regulatory Perspective: Concept of Quality in Clinical Trials

Ann Meeker O'Connell - Vice President, Integrated QMS/OMS, Vertex Pharmaceuticals

13:40 - 14:0020 mins

Presentation Title TBA - Triumph Research Intelligence (TRI)

14:00 - 15:0060 mins

Live Speaker Q&A and Roundtable Discussions

Christopher Biddle - Associate Director, Risk Management and Central Monitoring, Janssen Research