AAPS Workshop: "Drug Substance and Drug Product Specifications"

Venue: Arlington

Location: Arlington, Virginia, United States

Event Date/Time: Mar 18, 2002 End Date/Time: Mar 20, 2002
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Description

Sunday, March 17
5:00 pm - 7:00 pm
Registration

Monday, March 18
8:00 am - 5:00 pm
Registration

9:00 am
Welcoming Remarks

Yuan-yuan Chiu, Ph.D.
Food and Drug Administration

Diane Zezza, Ph.D.
Eli Lilly and Company

9:20 am
Overview of ICH Guidance Q6A
John Smith, Ph.D.
Food and Drug Administration

9:40 am
Overview of ICH Guidances Q3A, Q3B and Q3C
Chi-Wan Chen, Ph.D.
Food and Drug Administration

10:00 am
Philosophy Behind Setting Specifications
John Berridge, Ph.D.
Pfizer, Inc.

10:45 am
Break

11:15 am
Philosophy Behind Approving Specifications
Charles Hoiberg, Ph.D.
Food and Drug Administration

11:45 am
Lunch
Complimentary to all registrants

1:00 pm
Drug Substance: What Data Sets Are Available and When?
Jean Wyvratt, Ph.D.
Merck & Company

1:30 pm
Drug Product: What Data Sets Are Available and When?
Christopher Potter, Ph.D.
AstraZeneca

2:00 pm
What Data Sets Should Be Provided in an NDA?
Guirag Poochikian, Ph.D.
Food and Drug Administration

2:20 pm
Panel Discussion, Day One Speakers
Moderator
Yuan-yuan Chiu, Ph.D.

2:50 pm
Break

3:15 pm
Case Studies on Setting Specifications
Robert Baum, Ph.D.
Pharmacia Corporation

Martha Heimann, Ph.D.
Food and Drug Administration

4:15 pm
Panel Discussion
Moderator
Diane Zezza, Ph.D.

4:45 pm
Objectives and Logistics for Day Two
Diane Zezza, Ph.D.
Eli Lilly and Company

5:00 pm - 6:00 pm
Reception

Tuesday, March 19
7:30 am - 5:30 pm
Registration

8:00 am - 5:30 pm
Concurrent Breakout Sessions

8:00 am
A: Purity and Impurity Issues Concerning Drug Substance and Drug Product (process impurities, degradants and residual solvents) Related ICH Guidelines Q1A, Q3A, Q3B, Q3C and Q6A

B: Physical Properties: Particle Size, Polymorphs (Decision Trees in Q6A)

C: Decision Criteria for Miscellaneous Q6A Issues, such as: Skip Testing, Release vs. Shelf Specifications, Test Sunset and Interim Specification/Phase Commitment

D: Dissolution/Disintegration (Decision tree in Q6A)

E: Particulates and Container Closure Leachables in the Following Dosage Forms: Parenteral Products, Opthalmic Products, Inhalation Products

F: Particle Size Distribution Issues in the Following Dosage Forms: Inhalation Products, Suspension Products, Modified Release Solid Dosage Forms

9:35 am
Break

10:00 am
Breakout Sessions

11:30 pm
Lunch
Complimentary to all registrants

12:30 pm
Breakout Sessions

2:05 pm
Breakout Sessions

3:35 pm
Break

4:00 pm
Breakout Sessions

Wednesday, March 20
8:00 am - 12:00 pm
Registration

8:30 am
Reconvening Opening Remarks
Yuan-yuan Chiu, Ph.D.
Food and Drug Administration

8:40 am
Breakout Sessions A, B, C Summaries

9:40 am
Break

10:00 am
Breakout Sessions D, E, F Summaries

11:00 am
Panel Discussion

11:30 am
Overall Summaries, Conclusions and Next Steps
Yuan-yuan Chiu, Ph.D.
Food and Drug Administration

Diane Zezza, Ph.D.
Eli Lilly and Company

12:00 pm
Adjournment

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