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
ahofelich@gphaonline.org. Members of the public may register online at
http://www.gphaonline.org.
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.
Lunch
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.
Lunch
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.
http://www.gphaonline.org
Publication Date: 2006-10-12 02:00
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