Print Page   |   Contact Us   |   Sign In   |   Join
MDIC: Clinical Trial Innovation and Reform Workshop
Tell a Friend About This EventTell a Friend
 

This workshop will feature a full-day of presentations, panels and discussions digging deeper into the complexity of medical device clinical trials, including: CDRH's perspective on trial simplification, challenges and barriers to clinical trial innovation, results from the MDIC clinical trial study and actionable steps both industry and regulators can take to make innovation in medical device clinical trials a reality.

4/29/2015
When: April 29, 2015
8:30 a.m. - 4:30 p.m.
Where: Pew Charitable Trust Center
901 E Street NW
Washington, District of Columbia  20004
United States
Presenter: Medical Device Innovation Consortium
Contact: 952.314.1255

« Go to Upcoming Event List  

 

 

 

Join MDIC for the Clinical Trial Innovation and Reform Workshop Removing the Barriers to the Simplification of Medical Device Clinical Trials.

 

The workshop will feature a full-day of presentations, panels and discussions digging deeper into the complexity of medical device clinical trials, including: CDRH's perspective on trial simplification, challenges and barriers to clinical trial innovation, results from the MDIC clinical trial study and actionable steps both industry and regulators can take to make innovation in medical device clinical trials a reality.

 

8:30 a.m. Registration  
9:00 a.m. Welcome Bill Murray, MDIC
9:10 a.m. CDRH's Perspective on Clinical Trials Dr. Jeff Shuren, FDA
9:20 a.m. The Case for Clinical Trial Simplification Dr. Richard Kuntz, Medtronic
9:50 a.m. What Does CDRH Mean by Trial Simplification? Dr. Bill Maisel, FDA
10:10 a.m. Keynote: Challenges to Simplifying the Design and Analysis of Medical Device Pivotal Studies Dr. Philip Lavin
10:40 a.m. Moderated Discussion: Defining Trial Simplification and Potential Barriers

Dr. Kuntz, Dr. Lavin, Dr. Maisel

Moderator: Dr. Bill Voorhees

12:10 p.m. Lunch  
12:40 p.m. Keynote 2: A Clinician Investigator's Perspective on Medical Device Clinical Trial Innovation TBD
1:10 p.m.

Brief Overview of the MDIC Clinical Trial Data Study

Case Studies from the Study: How and Why Clinical Trials are Complex

Dr. Susan Alpert and members from CTIR Trial Simplification working group
2:10 p.m. Moderated Discussion: Proposing Solutions to Simplify Trial Designs and Improve Efficiency 

Dr. Alpert, Dr. Ira Spector, second keynote

Moderator: TBD

4:00 p.m. 

Next Steps/Action Plan

Closing Comments

Bill Murray

  

Creating Value
by delivering business-critical resources & bottom line savings
Building Networks
by connecting Michigan's bio-industry one member at a time
Growing Talent
by creating opportunities that develop people & build organizations
Membership Software Powered by YourMembership.com®  ::  Legal