MedCon 2010 Plenary SchedulePlenary Session Agenda

Compliance Update
  • Multiple Regulatory Agencies presenting the most significant issues/challenges they encounter
  • Summary presentation to tie it all together
  • Q&A with Panel
Global Approval Process
  • Multiple Regulatory Agencies discuss special requirements for new device approval, and change approval
  • Presentation to compare DHF to Technical Dossier
  • Q&A with Panel
Global Harmonization
  • Multiple Regulatory Agencies discuss initiatives occurring outside the US
  • Update on Global Harmonization Task Force and resulting FDA initiatives
  • Q&A with Panel

 

 

Stategic Committee Member

Karen Coleman, IHL Consulting, Inc.Karen Coleman

Senior Compliance Expert,
Medical Devices
IHL Consulting Group, Inc.
Former FDA National Medical Device Expert

“Device firms are competing in an ever expanding Global Market with emerging Regulatory issues every year.  This conference will help provide:  information about new challenges; highlight domestic and international activities impacting companies; and give insight on how the emerging Regulatory challenges affect FDA and other International Regulatory Entities.”