PharmaLabelingSummit2010
DAY ONE |
|
8:00 a.m. – 9:00 a.m. |
Registration/Continental Breakfast |
9:00 a.m. – 9:15 a.m. |
Co-Chair Welcome and Introduction |
9:15 a.m. – 10:00 a.m. |
FDA's Outlook for Labeling Capt. Laurie Beth Burke, Leader, Study Endpoints and Label Development Team, Office of New Drugs, CDER, FDA |
10:00 a.m. – 10:45 a.m. |
The Aftermath of Wyeth v. Levine — Preemption Considerations in Regulatory Negotiations and Submissions Attendees will learn:
Daniel Kracov, Partner, Arnold & Porter LLP |
10:45 a.m. – 11:00 a.m. |
Morning Break |
11:00 a.m. – 11:45 a.m. |
How SPL Is Shaping the Future of Labeling Attendees will learn:
Lonnie Smith, Project Manager, FDA Data Standards Council, CDER, FDA |
11:45 a.m. – 12:30 p.m. |
Implementation of Company Core Data Sheets and Implications for Local Labels Attendees will learn:
Alan Hassell, Independent Consultant, former Drug Regulatory Affairs Specialist, Hoffmann-LaRoche |
12:30 p.m. – 1:30 p.m. |
Lunch Break |
1:30 p.m. – 2:15 p.m. |
The Impact of Labeling on Advertising and Promotion Attendees will learn:
Maria Adriano, Scientist, Regulatory Affairs, Genentech |
2:15 p.m. – 3:00 p.m. |
FDAAA Authority to Mandate Labeling Changes Attendees will learn:
Scott Danzis, Partner, Covington & Burling LLP, former Special Assistant to the Chief Counsel, FDA |
3:00 p.m. – 3:15 p.m. |
Afternoon Break |
3:15 p.m. – 4:00 p.m. |
Determining Threshold and Causality When Considering Label Updates — How Safety Signals, REMS and Pharmacovigilance Are Influencing Labeling
Decisions Attendees will learn:
Mary Mease, Senior Director, Lifecycle Safety, Quintiles |
4:00 p.m. – 5:15 p.m. |
Panel Discussion: Tips on Working With the FDA on Adding Claims, Outcomes and Benefits Language
|
5:15 p.m. |
Adjourn |
DAY TWO |
|
8:00 a.m. – 8:30 a.m. |
Continental Breakfast |
8:30 a.m. – 8:45 a.m. |
Co-Chair Welcome and Introduction |
8:45 a.m. – 9:30 a.m. |
Is the FDA-Approved Labeling the Only Acceptable Form of Speech About Approved Drug Products? Attendees will learn:
Coleen Klasmeier, Partner, Sidley Austin, former Special Assistant to the Chief Counsel, FDA |
9:30 a.m. – 10:15 a.m. |
Pharmacogenomics and Labeling — Threat or Opportunity? Attendees will learn:
Dr. Robert Epstein, Chief Medical Officer and President, Medco Research Institute |
10:15 a.m. – 11:00 a.m. |
Put Away the PowerPoint Panel Discussion and Closing Comments
|
11:00 a.m. |
Adjourn |