GPhA, FDA To Focus On Science And Regulatory Issues At The 2007 Fall Technical Conference

Main Category: Pharma Industry / Biotech Industry
Also Included In: Pharmacy / Pharmacist;  Conferences
Article Date: 03 Oct 2007 - 14:00 PDT

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Current and future scientific and regulatory issues for the generic pharmaceutical industry will be the focus of the Generic Pharmaceutical Association's (GPhA) Fall Technical Conference on October 10-11, 2007. This annual conference brings together industry and Food and Drug Administration (FDA) representatives for a unique dialogue on topics such as the FDA Question-based Review initiative, current good manufacturing practices, bioequivalence, and the generic drug regulatory environment.

"Each year, the Fall Technical Conference provides the generic industry with an unparalleled opportunity to discuss key science and regulatory issues with FDA," said GPhA President and CEO Kathleen Jaeger. "Communication is a two-way street, and we look forward to this annual conference to foster increased dialogue to ensure the timely delivery of affordable, safe and effective generics to consumers."

Featured speakers include Doug Long, Vice President for Industry Relations at IMS Health; Gary Buehler, Director of the FDA Office of Generic Drugs (OGD); Elizabeth Dickinson, FDA Associate Chief Counsel for Drugs; and other senior FDA officials.

The plenary sessions begin at 8:30 a.m. on October 10 and at 8 a.m. on October 11. The conference will be held at the Marriott Bethesda North Hotel and Conference Center located at 5701 Marinelli Road in North Bethesda, Maryland.

Conference Agenda

Wednesday, October 10

8:30 a.m.-8:45 a.m.
Welcome and Introductions
Kathleen Jaeger, President and CEO, GPhA

8:45 a.m.-9:45 a.m.
Initiatives in the New Paradigm
Helen Winkle, Director, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research (CDER), FDA

9:45 a.m.-10:45 a.m.
Industry Trends and Analysis
Doug Long, Vice President of Industry Relations, IMS Health

10:45 a.m.-11:15 a.m.
Refreshment Break

11:15 a.m.-12:15 p.m.
Current Topics in the CDER Compliance Program
Deborah Autor, Director, Office of Compliance, CDER, FDA

12:15 p.m.-1:30 p.m.
Lunch

1:30 p.m.-2:30 p.m.
Bioequivalence: Recent Developments and Ongoing Issues Dale Connor, Pharm.D., Director, Division of Bioequivalence, OGD, FDA

2:30 p.m.-3:30 p.m. Track A: Plenary Session -- Navigating the e-CTD and Regulatory
Landscape
Saundra Middleton, Project Manager, Regulatory Support Branch, OGD, FDA
Jeen Min, R.Ph., Project Manager, Regulatory Support Branch, OGD, FDA

Track B: Breakout Session -- Clinical Endpoint Studies -- Protocol and Study Recommendations
Dena Hixon, M.D., Associate Director for Medical Affairs, OGD, FDA

3:30 p.m.-4:00 p.m.
Refreshment Break

4:00 p.m.-5:00 p.m.
Track A: Plenary Session -- Today's Issues in Drug Master Files
Paul Schwartz, Ph.D., Deputy Division Director, Chemistry I, OGD, FDA

Track B: Breakout Session -- Clinical Endpoint Studies -- Protocol and
Study Recommendations (continued)

Thursday, October 11, 2007

8:00 a.m.-10:00 a.m. Track A: Recent Developments in the Legal
Landscape
Elizabeth Dickinson, Associate Chief Counsel for Drugs, FDA
Bill Rakoczy, Partner, Rakoczy, Molino, Mazzochi, Siwik, LLP

Track B: Sterility Assurance: Optimization of Sterility Assurance Submissions
Neal Sweeney, Ph.D., Team Leader, Microbiology Review Team, OGD, FDA

10:00 a.m.-10:30 a.m.
Refreshment Break

10:30 a.m.-11:00 a.m.
Question-based Review: An Update
Lawrence Yu, Ph.D., Director for Science, OGD, FDA

11:00 a.m.-11:30 a.m.
Question-based Review: A Reviewer's Perspective
Bita Mirzai-Azarm, Chemist, OGD, FDA

11:30 a.m.-12:00 p.m.
Question-based Review: A Team Leader's Perspective
Scott Furness, Team Leader, OGD, FDA

12:00 p.m.-1:30 p.m.
Lunch

1:30 p.m.-2:00 p.m.
Question-based Review: Understanding Design Questions
Robert Lionberger, Chemical Engineer, OGD, FDA

2:00 p.m.-3:00 p.m.
Question-based Review: Panel Discussion
FDA/Industry Panel, TBD

3:00 p.m.-3:30 p.m.
Update on Labeling Issues
Koung Lee, Labeling Reviewer, OGD, FDA

3:30 p.m.-4:00 p.m.
Refreshment Break

4:00 p.m.-5:00 p.m.
Office of Generic Drugs Update
Gary Buehler, R.Ph., Director, OGD, FDA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 63% of the total prescriptions dispensed in the United States, but only 20% of all dollars spent on prescription drugs.

http://www.gphaonline.org