Cambridge Healthtech Institute’s Inaugural
Medical Device Clinical Trial Operations and Regulations
Navigating Regulations and Operational Challenges for Quality Medical Device Clinical Trials
February 19-20, 2020
The medical device industry comes with its own set of unique challenges when it comes to clinical trials, especially in light of the new medical device regulation coming out of the EU. CHI's Inaugual Medical Device Clinical Trial Operations and Regulations
conference will offer insight into navigating this new regulation ahead of the May 2020 deadline, as well as insights into pre- and post-market studies. The conference will also take a deep dive into risk-based monitoring for device trials and the
impact of ICH E6 R2.
Stay on and attend Part 2 (Thurs-Fri): Implementing Risk-Based Monitoring (Part 2)
MDR Is Nearly Here – Are You Ready for the New Normal?
Bill Bordeau, Director, Global Clinical Operations, Biostatistics, and Clinical Data Management, Zimmer Biomet
Pre- and Post-Market Studies: Addressing Challenges Unique to Medical Devices
Jane M. Jacob, PhD, CCRP, Vice President, Research and Clinical Affairs, Orthofix, Inc.
Pre- and Post-Market Studies: Use of Real Word Data (RWD)
Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific Corporation
Addressing Risk-Based Monitoring of Device Trials and the Impact of ICH E6 R2
Michelle Wetherby, Associate Director, Global Clinical Operations, Abbott
CO-PRESENTATION: Risk-Based Monitoring at Johnson & Johnson: From Pharma to Medical Device Clinical Trials
Stephanie Clark, Director, Risk Management-Central Monitoring, Janssen R&D (J&J)
Erin Creedon, Associate Director, Clinical Operations, Ethicon (J&J)
Risk-Based Quality and Compliance Management in Clinical Trials with Combination Products
Marina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine