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)

Preliminary Agenda


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


Tuesday Evening, Wednesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

For more details on the Plenary Keynotes:
For more details on the Participant Engagement Award:


Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing:


Stay on and attend Part 2 (Thurs-Fri): Implementing Risk-Based Monitoring (Part 2)

For more details on the conference, please contact:
Kaitlin Searfoss Kelleher

Director, Conferences

Cambridge Healthtech Institute

Phone: (+1) 781. 972.5498


For partnering and sponsorship information, please contact:

Companies A-K

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.5457



Companies L-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.1349