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