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    GPhA, FDA To Focus On Science And Regulatory Issues For The Generic Pharmaceutical Industry At 2006 Fall Technical Conference
Wed.-Thu., October 18-19, Bethesda Marriott North, Bethesda, Maryland.

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 18-19, 2006. 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 issues, and the generic drug regulatory environment.

"The conference represents an ongoing partnership between FDA and the generic industry to discuss key issues in science and regulation," said GPhA President and CEO Kathleen Jaeger. "Each year, we're pleased to provide the industry with an opportunity to hear firsthand about important issues FDA is working on and offer our input."

Featured speakers will include Kathleen Jaeger, GPhA President and CEO; Steven Galson, Director for the FDA Center for Drug Evaluation and Research (CDER); Gary Buehler, Director of the FDA Office of Generic Drugs (OGD); and other key officials from the FDA with jurisdiction over generic drugs.

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

Registration is complimentary for credentialed reporters. Reporters may register for the event by contacting Andrea Hofelich at 703-647-2495 or Members of the public may register online at

Conference Agenda

Wednesday, October 18

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

8:45 a.m.-9:30 a.m.
A View From the Top
Steven K. Galson, M.D., Director, CDER, FDA

9:30 a.m.-10:30 a.m.
Regulatory Update/OGD Panel
Marty Shimer, R.Ph., Supervisor, Regulatory Support Branch, OGD, FDA
Christine Bina, R.Ph., Regulatory Support Branch, OGD, FDA

10:30 a.m.-11:00 a.m.
Refreshment Break

11:00 a.m.-12:30 p.m.
Legal Update
David Read, Regulatory Counsel, CDER, FDA
Robert Dormer, Managing Partner, Hyman, Phelps & McNamara

12:30 p.m.-1:45 p.m.

1:45 p.m.-2:45 p.m.
Track A: Plenary Session
Update on Bioanalytical Laboratory Inspections
C.T. Viswanathan, Ph.D., Associate Director, Division of Scientific Investigations, FDA

Track B: Breakout Session
Key Issues in Sterility Assurance Submissions
Neal Sweeney, Ph.D., Team Leader, Microbiology, CDER, FDA

2:45 p.m.-3:45 p.m.
Bioequivalence Issues
Dale Conner, Pharm.D., Director, Division of Bioequivalence, OGD, FDA

3:45 p.m.-4:15 p.m.
Refreshment Break

4:15 p.m.-5:15 p.m.
Track A: Plenary Session
Implementation of ICH Q8, Q9, and Q10 Guidances
Nick Cappuccino, Ph.D., Andrx Pharmaceuticals
Jennifer Barrett, Barr Laboratories

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

Thursday, October 19, 2006

8:30 a.m.-9:30 a.m.
Chemistry Review Issues and Update
Frank Holcombe, Ph.D., Associate Director for Chemistry, OGD, FDA
Lawrence Yu, Ph.D., Director for Science, OGD, FDA

9:30 a.m.-10:30 a.m.
Question-based Review
Lawrence Yu, Ph.D., Director for Science, OGD, FDA

10:30 a.m.-11:00 a.m.
Refreshment Break

11:00 a.m.-11:30 a.m.
Question-based Review

11:30 a.m.-12:30 p.m.
Question-based Review Panel
FDA/Industry representatives

12:00 p.m.-1:45 p.m.

1:45 p.m.-3:00 p.m.
Compliance Issues/483 Trends
Joe Famulare, Acting Deputy Director, Office of Compliance, CDER, FDA
Anthony Charity, Consumer Safety Officer, CDER, FDA

3:30 p.m.-4:00 p.m.
21st Century Quality Initiatives
Helen Winkle, Director, Office of Pharmaceutical Sciences, CDER, FDA

4:00 p.m.-5:00 p.m.
Office of Generic Drugs in Review
Gary Buehler, R.Ph., Director, Office of Generic Drugs, 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 56% of the total prescriptions dispensed in the United States, but only 13% of all dollars spent on prescription drugs.

Publication Date: 2006-10-12 02:00

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