Pharmaceutical Labeling Summit 2011 Agenda
Revised as of Sept. 8, 2011
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 Dave Ceryak, Senior Director, Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company |
9:05 a.m. – 10:15 a.m. |
Keynote Address: Understanding the Safety Labeling Changes — Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act Guidance Attendees will learn:
Dr. Susan Honig, Medical Reviewer, Office of New Drugs, CDER, FDA |
10:15 a.m. – 11:00 a.m. |
The Tipping Point of FDA's Public Health Voice: Has the Proliferation of Warnings Diminished the Agency's Impact on Clinical Practice Attendees will learn:
Dr. Scott Gottlieb, Resident Fellow, American Enterprise Institute, former Deputy Commissioner for Medical and Scientific Affairs, FDA |
11:00 a.m. – 11:15 a.m. |
Morning Break |
11:15 a.m. – 12:00 p.m. |
How SPL Is Shaping the Future of Labeling Attendees will learn:
Lonnie Smith, Project Manager, FDA Data Standards Council, CDER, FDA |
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. |
Spotlight on Recent and Pending Labeling-Related Cases — Including Matrixx v. Siracusano and PLIVA Inc. v. Mensing Attendees will learn:
Coleen Klasmeier, Partner, Sidley Austin, former Special Assistant to the Chief Counsel, FDA |
2:30 p.m. – 3:15 p.m. |
Two Very Important Square Inches — How USP’s New Labeling Standards Can Improve Patient Comprehension Attendees will learn:
Dr. William Shrank, Associate Physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Member of Committees on Prescription Drug Labeling for the American College of Physicians Foundation and for the USP |
3:15 p.m. – 3:30 p.m. |
Afternoon Break |
3:30 p.m. – 4:15 p.m. |
FDA Update on Patient Medication Information (PMI) Attendees will learn:
Bryon Pearsall, JD, RPh, Health Scientist Policy Analyst, Office of Medical Policy, CDER, FDA |
4:15 p.m. – 5:00 p.m. |
The role of Labeling in Class Action and Failure-to-Warn Liability Litigation Attendees will learn:
Andrew Kantra, Partner, Pepper Hamilton |
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. – 9:05 a.m. |
Chair Welcome and Introduction Dr. Leander Fontaine, Principal Consultant, Pharmiceutics, former Head of Labeling, Wyeth |
9:05 a.m. – 10:15 a.m. |
Keynote Address: ANDA Labeling — Current Status of the FDA’s Labeling Review and Approval Process Attendees will learn:
Koung Lee, RPh, MSHS, Commander, U.S. Public Health Service, Team Leader, Labeling Review Branch, Division of Labeling and Program Support, Office of Generic Drugs, Office of Pharmaceutical Science, CDER, FDA |
10:15 a.m. – 12:45 p.m. |
Panel Discussion: For New Products, Can We Submit the Same List of ADRs in Canada, EU, Japan and the USA? Attendees will learn:
Moderator and Introductory Presentation: Dr. Leander Fontaine, President, Pharmiceutics LLC Panelists:
|
12:45 p.m. – 1:45 p.m. |
Lunch Break |
1:45 a.m. – 4:15 p.m. |
Panel Discussion: What Could an Actual Biosimilars Label Look Like? Watch One Built Before Your Eyes Moderator and Introductory Presentation: Dr. Leander Fontaine, President, Pharmiceutics LLC Panelists:
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4:15 p.m. – 4:30 p.m. |
Day Two Adjourn, Closing Remarks |