10000 W O'Hare ave
Chicago, IL 60666
USA
Scientific, Regulatory, and Operational Best Practices for academic and industry thought leaders involved in adjudication.
Kenneth Mahaffey, MD
Co-Chair, Duke/Stanford CEC Summit
Professor, Stanford University School of Medicine
Vice Chair of Clinical Research, Department of Medicine
Director, Stanford Center for Clinical Research (SCCR)
Renato D. Lopes, MD, MHS, PhD
Co-Chair, Duke/Stanford CEC Summit
Professor of Medicine, Division of Cardiology
Duke University Medical Center
Director, CEC-SS, Duke Clinical Research Institute (DCRI)
An exciting new clinical events classification and safety meeting is taking place September 26-27 in Chicago, coordinated by the Duke Clinical Research Institute and the Stanford Center for Clinical Research.
Designed for academic and industry thought leaders involved in adjudication, the two-day symposium promises to deliver provocative and challenging discussions on trends in the industry and the development of CEC/safety best practices, strategies, and quality standards.
We will bring together thought leaders from academia, the FDA, and industry to moderate informative sessions, including topics such as CEC audit readiness, emerging trends in safety and efficacy, new technologies, and data quality and standards.
Early Bird pricing is available through July 15, so register today!
Tentative Program Agenda
Day 1
8:45 a.m.–9:00 a.m.
Opening Remarks & Welcome: Renato Lopes (DCRI) and Ken Mahaffey (SCCR)
9:00 a.m.–12:00 p.m.
Breakout Sessions on Quality: Moderators Karen Hicks (FDA) and Ken Mahaffey (SCCR)
- Session #1: CEC Quality and Audit Readiness: Karen Hicks (FDA) and Maria Ali (George Clinical)
- Session #2: Emerging Trends in Safety & Efficacy: Venu Menon (CCF) and Ghazala Haque (DCRI)
- Session #3: TBA Panel Discussion
12:00 p.m.–1:00 p.m. Break for Lunch and Networking
1:00 p.m.–4:00 p.m.
Breakout Sessions on Efficiency: Moderators Bernard Chaitman (St. Louis) and Renato Lopes (DCRI)
- Session #4: CEC Efficiency and Technology: Michael Gibson (Harvard) and Amol Rajmane (SCCR)
- Session #5: A New Era in Data: Scott Solomon (Harvard) and Michael Pencina (DCRI)
- Session #6: TBA Panel Discussion
4:00 p.m.–4:30 p.m. Closing Remarks, Moderator/Speakers and Audience Engagement
4:30 p.m.–5:30 p.m. Cocktail Reception for Networking
Day 2
8:45 a.m.–9:00 a.m.
Opening Remarks & Welcome: Renato Lopes (DCRI) and Ken Mahaffey (SCCR)
9:00 a.m.–11:00 a.m.
Breakout Sessions on Collaboration: Moderators: Steve Wiviott (TIMI) and Jonathan Seltzer (ACI Clinical)
- Session #7: Collaboration and Consensus – Standards Around Data, Definitions and Operational Workflow: Steve Wiviott (TIMI) and Matthew Wilson (DCRI)
- Session #8: Strategies and Best Practices: Roxana Mehran (CRF) and Mark Hlatky (Stanford)
11 a.m.–12:00 p.m.
Final Session and Panel Discussion
12:00 p.m.–1 p.m.