Wednesday, November 1
11:30 AM–12:00 PM
Registration and Lunch
12:00–12:10 PM
Welcome and Course Overview
Khara L. Minter, Assistant Director, Training Programs, FDLI
William A. McConagha, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
12:10–1:55 PM
I. Applicable FDA Offices, Essential Principles, & Key Definitions
Georgia C. Ravitz, Partner, Wilson Sonsini Goodrich & Rosati
1:55–2:10 PM
Break
2:10–2:55 PM
II. Dissemination of Non-Promotional Information
Philip Defedele, Senior Associate, Arnold & Porter LLP
2:55–3:10 PM
Break
3:10–3:55 PM
III. Other Agencies and Considerations
Marc J. Scheineson, Partner, Alston & Bird LLP
3:55–4:10 PM
Break
4:10–5:00 PM
IV. Case Studies/Hypotheticals
Alan G. Minsk, Partner and Leader, Food and Drug Practice Team, Arnall Golden Gregory LLP
5:00 PM
Welcome Reception
Reception will be hosted at:
Skadden, Arps, Slate, Meagher & Flom LLP
1440 New York Avenue NW
Washington, DC 20005