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

 

I am pleased to announce CHI’s Inaugural “Medical Device Clinical Trial Operations and Regulations” being held February 19-20, 2020 at the Hyatt Regency Orlando in Orlando, FL. The gathering will be part of the 11th Annual Summit for Clinical Trials Operations Executives (SCOPE), a four-day cluster of events that attracted 2,000 leaders in clinical innovation, operations and research in 2019. Topics to be discussed at the “Medical Device Clinical Trial Operations and Regulations” conference include:  

 

  • Navigating the new of Clinical Trial Regulation EU No. 536/2014: what it means for device companies, how to update current processes, and strategies to develop new ones
  • Data privacy and informed consent under the new regulation
  • Developing a robust clinical team and trial process for companies having to conduct clinical trials for the first time
  • Understanding submission to the FDA and IRBs
  • Challenges and best practices related to conducting preceptor training
  • Understanding rules and regulations for trials conducted in the US vs. the EU
  • Risk-based monitoring for medical device clinical trials and the impact of ICH E6 R2
  • Post-market vs. pre-market studies

 

If you would like to submit a proposal to give a presentation at this meeting, please click here.

 

The deadline for priority consideration is May 30, 2019.

 

All proposals are subject to review by session chairmen and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

 

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

Director, Conferences

Cambridge Healthtech Institute

Phone: (+1) 781. 972.5498
Email: kkelleher@healthtech.com

 

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

Email: iquigley@healthtech.com

 

Companies L-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.1349
Email: prose@healthtech.com