Duke/Stanford CEC Summit Set for Sept 26-27

September 26-27, 2018 | Chicago Hilton O'Hare

Scientific, Regulatory, and Operational Best Practices for academic and industry thought leaders involved in adjudication.

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

CEC Summit Co-Chairs

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)

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.
Session on Quality

·       Discuss current quality metrics in event adjudication

·       How to prepare for a regulatory or industry audit

·       Mechanisms to integrate safety reporting and event adjudication
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: Panel Discussion (Objective:  promote attendee and speaker interaction to share best practices across institutions and CEC groups on quality)

 

12:00 p.m.–1:00 p.m.
Break for Lunch and Networking

 

1:00 p.m.–4:00 p.m.

Session on Efficiency

·       Review historical operations of CEC

·       Discuss leveraging technology to improve efficiency of CEC processes

·       Understand how big data and AI can improve CEC – Where are we now?
Moderators: Bernard Chaitman (St. Louis) and Renato Lopes (DCRI)

Session #4: CEC Efficiency and Technology
C. Michael Gibson (Harvard) and Amol Rajmane (SCCR)

Session #5: A New Era in Data

Akshay Desai (Harvard) and Frank Rockhold (DCRI)

Session #6: Panel Discussion (Objective:  promote attendee and speaker interaction to share best practices across institutions and CEC groups on processes and leveraging technology)

 

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.
Session on Collaboration

·       Discuss the regulatory, industry and academic perspectives on CEC

·       Review implementation of current standardized definitions – Successes and Pitfalls

·       Discuss the importance of event adjudication collaboration and distributive operations model
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
(Objective:  promote attendee and speaker interaction to share best practices and recognize opportunities for improvement of CEC practices)

12:00 p.m.–1 p.m.
Lunch and Networking