Pharmaceutical Labeling Summit 2012 Agenda
DAY ONE |
|
8:00 a.m. – 9:00 a.m. |
Registration and Continental Breakfast |
9:00 a.m. – 9:05 a.m. |
Chair Welcome and Introduction |
9:05 a.m. – 9:50 a.m. |
The FDA’s Expectations for Compliant Labeling in 2013 and Beyond Attendees also will learn:
|
9:50 a.m. – 11:00 a.m. |
Examination of How the FDA Applies Boxed Warnings |
11:00 a.m. – 11:15 a.m. |
Morning Break |
11:15 a.m. – 12:00 p.m. |
Accessing Package Insert (Content of Labeling) Information Via Mobile Devices Attendees will learn:
|
12:00 p.m. – 1:30 p.m. |
Lunch Break |
1:30 p.m. – 1:45 p.m. |
Recap of Morning Sessions |
1:45 p.m. – 2:30 p.m. |
Downstream Use of SPL Attendees will learn:
|
2:30 p.m. – 3:15 p.m. |
ANDA Labeling — Current Status of the FDA’s Labeling Review and Approval Process Attendees will learn:
|
3:15 p.m. – 3:30 p.m. |
Afternoon Break |
3:30 p.m. – 4:15 p.m. |
Do Drug Product Labels Confirm and Correct Consumers' Medication Preconceptions?
|
4:15 p.m. – 5:00 p.m. |
The Impact of Labeling on Advertising and Promotion
|
5:00 p.m. – 7:00 p.m. |
Cocktail Reception and Networking |
DAY TWO |
|
8:00 a.m. – 9:00 a.m. |
Continental Breakfast |
9:00 a.m. – 9:15 a.m. |
Chair Welcome and Introduction |
9:15 a.m. – 10:15 a.m. |
The Role of Labeling in REMS: Examples from the Opioid and Other REMS Attendees will learn:
|
10:15 a.m. – 12:45 p.m. |
Panel Discussion: Pilva v. Mensing Redux? What Does the First Circuit Court of Appeals Decision in Barlett v. Mutual Mean for Generic Preemption? |
12:45 p.m. – 1:45 p.m. |
Lunch Break |
1:45 a.m. – 4:15 p.m. |
Panel Discussion: Determining Threshold and Causality When Considering Label Updates — How Safety Signals, REMS and Pharmacovigilance Are Influencing Labeling Decisions |
4:15 p.m. – 4:30 p.m. |
Day Two Adjourn, Closing Remarks |