MedCon 2010 Clinical Track AgendaClinical Track Agenda

Information will be updated as the agenda detail is finalized.

  • The IDE Process
  • Pre-IDE Meeting Preparation
  • Understanding Clinical Trial Requirements:

           Medical Devices
           Combination Products
           International Clinical Trials

  • Study Design (design/protocol change, FDA input)
  • Integrating clinical trial system into a Quality System
  • Joint Session with Regulatory:  integrating regulatory and clinical plans

Strategic Committee Member

Ken Sumner, Ethicon Endo-SurgeryKen Sumner

WW VP, Clinical and Regulatory Affairs
Ethicon Endo-Surgery, Inc. a J&J Company
 
 

“The trend in health care is to reduce costs by focusing on which procedures/products provide the best outcome for the patient.  Increasingly, it will be the data gathered in clinical studies that will provide the evidence that will be relied upon by providers, payers, physicians and patients in making these treatment choices.”

Please contact Marla Phillips if you would like to be considered for speaker or moderator opportunities.