Cambridge Healthtech Institute’s 2nd Annual

Medical Device Trial Regulations, Quality and Data Management

Navigating a Changing Regulatory Landscape and Accelerating Approvals

March 3-4. 2021

 

I am pleased to announce CHI’s 2nd Medical Device Trial Regulations, Quality and Data Management  being held March 3-4, 2021 at Rosen Shingle Creek in Orlando, FL. The gathering will be part of the 12th Annual Summit for Clinical Trials Operations Executives (SCOPE), a four-day cluster of events that attracted 2,200 leaders in clinical innovation, operations. and research in 2020. Topics to be discussed at the Medical Device Trial Regulations, Quality and Data Management conference include:

 

  • Understanding rules and regulations for trials conducted in the US vs. the EU
  • Implementing risk-based monitoring for medical device trials
  • Emergency use authorizations in a post-COVID world
  • Regulatory updates: What COVID-related changes are here to stay?
  • Impact of remote trials on IRB approval process
  • Regulatory and data considerations for device combination product trials
  • Next-generation clinical data strategy
  • In vitro diagnostics regulation (IVDR): Planning for the 2022 deadline
  • Considerations for attaining accreditation under new MDR requirements

 

Also, please check out the Participant Engagement Award in honor of Gerald “Jerry” Matczak, the SCOPE Scientific Symposium (SSS), and the Masters in Clinical Research Golf Tournament.

 

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

 

The deadline for priority consideration is July 31, 2020.

 

All proposals are subject to review by session chairpersons 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:

Bridget Kotelly
Conference Producer

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781-972-5404

Email: bkotelly@cambridgeinnovationinstitute.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