Office of Technology Commercialization

Invention 2 Innovation: “Considerations for Clinical Trials... A Regulatory Attorney’s Perspective”

Section: News Items

Presented by

Alan G. Minsk

Partner and Chair of the Food & Drug Practice Team

Arnall Golden Gregory LLP

Thursday, June 25, 2009

12:00 noon – 1:00 pm

Leavey Program Center

Lunch will be provided, space is limited

 Please RSVP

This seminar will cover the following:

I.                    Overview of FDA Approval Process, Including INDs/IDEs, the Testing Phases and Institutional Review Boards

II.                 Contractual issues- IP ownership, Publications, Biological Material Ownership, Confidentiality

III.               (Some of) the Sponsor and Investigator’s Requirements

 About the speaker:  Alan Minsk advises pharmaceutical, medical device and food companies on all legal and regulatory matters relating to the U.S. Food and Drug Administration and the Drug Enforcement Administration.

 For additional information contact Azra Furbach at acf43@georgetown.edu or 202-687-7424.

 This seminar series of interactive sessions will explore broad issues involved in transforming ideas into marketable products and processes and is intended for faculty, entrepreneurs, fellows, students, and research administrators.