November 28 - 29, 2001

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD


Day 1: Wednesday, November 28, 2001

8:30 Call to Order Vincent H. L. Lee, Ph.D., Acting Chair

Conflict of Interest Nancy Chamberlin, Pharm.D., Exec.Sec.

8:45 Introduction to Meeting Helen Winkle, Acting Director OPS

9:00 Process Analytical Technology Subcommittee

Introduction and Overview Ajaz Hussain, Ph.D.,

Update from Science Board Deputy Director OPS

Objectives for subcommittee

Committee Discussion

Invited Guests:

Tom Layloff, Ph.D., Pharm. Science Consultant

10:30 Break

10:45 Stability Testing and Shelf-life

Introduction to Issues Ajaz Hussain, Ph.D

Deputy Director OPS

Committee Discussion

Invited Guests

Christopher Rhodes, Ph.D., Univ. Rhode Island

Pharmacy Compounding Committee Member

12:30 Lunch

1:30 Open Public Hearing

2:30 Blend Uniformity and Potential Impact of PQRI Research

Introduction to the Issues Ajaz Hussain, Ph.D. .

Deputy Director OPS

Data presentation

3:00 Break

3:15 Blend Uniformity - continued

Committee Discussion

Invited Guests

Thomas Garcia, Ph.D., Purepac Pharmaceutical Company

Garth Boehm, Ph.D., Pfizer Inc.

4:15 Update of other Subcommittees and CDER Guidances Committee

Nonclinical Studies Subcommittee John Doull, Ph.D.

ACPS Committee Member

Drug Safety and Risk Management Martin Himmel, M.D.

Subcommittee OPDRA ORM

4:30 Adjourn

(Note: 4:30 - 5:30 Training for ACPS Members)