(This an exclusive event for MedTech, BioTech and  Life Science C-Level executives)

Evolution or Revolution?
The Changing FDA Environment for Device Regulation

(Registration- 11:00 a.m., Lunch/Panel Discussion- 11:30a.m.-12:30p.m.)

Moderator: Timothy Devlin, Partner of Fish and Richardson P.C.

PACT invites it Life Science members and guests for a panel discussion on the 510K application process. The FDA has recently been under intense scrutiny by Congress and the media regarding its process for regulation of medical devices. Following an overview of the recent debate and the potential for new FDA guidance, the panel will discuss how the changes in the FDA regulatory environment will impact industry. Panel members from industry, government, and legal/regulatory sectors will address the implications of the current environment for product approval timelines, clinical data requirements, and total product life cycle planning.

Panelists:

• Janice Hogan, Managing Partner of Hogan Lovells’ Philadelphia office and Co-Director of the law firm’s FDA/Medical Device practice. Hogan represents medical device, pharmaceutical and biological product manufacturers before the U.S. Food and Drug Administration
• Wesley Kaupinen, Principal of Quaker BioVentures, Inc.
• Dr. Daniel Schulz, Senior Vice President, Medical Devices and Combination Products of Greenleaf Health, and former Director of the Center for Devices and Radiological Health at FDA.
• Sujat Sukthankar, Ph.D., Vice President Devices R&D, Endo Pharmaceuticals
  This is a three part event. If you are not a golfer please join us for the lunch and panel discussion and/or the cocktail reception. (Registration- 11:00 a.m., Lunch/Panel Discussion- 11:30a.m to 12:30p.m., Shotgun Start-12:45p.m. and Cocktails- Immediately after golf concludes).
  
  Sponsors: Ernst & Young, Fish & Richardson, Quaker Bioventures and Safeguard Scientifics
  
  The registration fee for event are listed below:
  Luncheon/Panel Discussion only
  $20.00 for Members
  $55.00 for non-members
  
  Luncheon, Golf and Cocktail Reception
  $90.00 for members
  $160.00 for non-members
  
  Space is limited for both lunch and golfers, so please register today via reply email to Kim Tuski at Ktuski@philadelphiapact.com or call 215-790-3860.