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Day 1 - EST
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Day 1 - EST
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9:15am - 10:00am45 mins
Let's get moving PT HIIT Session
10:05am - 10:15am10 mins
Platform Tutorial
10:15am - 10:20am5 mins
Welcome and Opening Remarks
10:25am - 10:30am5 mins
Meet our Non-Profit Partner - JerseySTEM
10:30am - 10:50am20 mins
Leadership Perspective: Change Management
- Johann Proeve, Ph.D. - Chief Scientific Officer, Cyntegrity
- Nico Wegener, Ph.D. - Senior Clinical Project Manager, Merz Pharmaceuticals
10:55am - 11:15am20 mins
State of the Industry Report
- Steve Young - Chief Scientific Officer, CluePoints
11:15am - 11:20am5 mins
Take a Break and Visit our Virtual Exhibit Hall!
11:20am - 12:00pm40 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
12:05pm - 12:25pm20 mins
Regulatory Review: ICH E8 and ICH E6v3 - How do they Impact RBM and You!
- Andy Lawton - Director, Risk-Based Approach Ltd
12:25pm - 1:25pm60 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!
1:25pm - 1:45pm20 mins
Regulatory Perspective: Concept of Quality in Clinical Trials
- Ann Meeker O'Connell - Vice President, Integrated QMS/OMS, Vertex Pharmaceuticals
1:50pm - 2:10pm20 mins
Pivoting RBQM to Mitigate COVID-Borne Risks
- Kristin Stallcup - Senior Director, Xcellerate Customer Success, Covance
2:15pm - 2:35pm20 mins
ICH E6(R3) Review: RBQM Considerations within Annex 2 Applied to Non-Traditional Trials
- Steve Whittaker - Senior Consultant, The Avoca Group
2:40pm - 3:40pm60 mins
Live Speaker Q&A
- Lisa Henderson - Group Content Director, Applied Clinical Trials and Pharmaceutical Executive, MJH Associates Inc.
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