ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

April 13-14, 2004

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD

AGENDA

Day 1: Tuesday, April 13, 2004

 

8:30 Call to Order Art Kibbe, Ph.D., Chair

 

Conflict of Interest Hilda Scharen, Exec. Sec.

8:45 Introduction to Meeting Helen Winkle, Director OPS

OPS Update

Pharmaceutical Quality for the 21st Century

 

9:00 Subcommittee Reports

Clinical Pharmacology .

9:15 Parametric Tolerance Interval Test Ajaz Hussain, Ph.D.

for Dose Content Uniformity

 

FDA Perspective

IPAC-RS Perspective

 

Committee Discussions and Recommendations

 

10:15 Break (15 minutes)

10:30 Process Analytical Technologies (PAT) Next Steps

Finalizing PAT Guidance

Rapid Microbial Methods

Standards Development

Training and Certification

 

Committee Discussions and Recommendations

 

12:00 Lunch

 

1:00 Open Public Hearing

 

2:00 PAT Applications for products in Office of Biotechnology Products (OBP)

Overview and Issues

 

3:00 Break (15 minutes)

 

Committee Discussion and Recommendations

 

5:00 Adjourn


ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

April 13-14, 2004

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD

AGENDA

 

Day 2: Wednesday, April 14, 2004

 

8:30 Call to Order Art Kibbe, Ph.D., Chair

 

Conflict of Interest Hilda Scharen, Exec.Sec.

 

8:45 Bioequivalence of Highly Variable Drugs

Issues and challenges

 

10:00 Break (15 minutes)

 

Committee Discussion and Recommendations

 

12:00 Lunch

 

1:00 Open Public Hearing

 

2:00 BioINequivalence Concept and Definition

 

2:45 Break (15 minutes)

 

Committee Discussion and Recommendations

 

3:30 Update -- Topical Bioequivalence

4:15 Future Topics - Nanotechnology

 

4:45 Conclusion and Summary Remarks Ajaz Hussain Ph.D.

 

5:00 Adjourn