Drugs
CDER Forum for International Drug Regulatory Authorities, April 20 - 24, 2009, Silver Spring, MD
Monday, April 20, 2009
Overview of Process and Structure
Time | Topic | Presenter |
|---|---|---|
| 8:30am – 9:00am | Registration | |
| 9:00am – 10:00am | Welcome and Introduction (PDF - 2473KB) | Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA |
| 10:00am – 10:30am | FDA’s International Program (PDF - 268KB)
| Walter Batts Deputy Director Office of International Programs Office of the Commissioner FDA |
| 10:30am – 10:45am | Break | |
| 10:45am – 11:15am | Role of CDER (PDF - 1753KB) | Mary E. Kremzner, Pharm.D. Associate Director Division of Drug Information CDER, FDA |
| 11:15am - 12:15pm | ICH and the Common Technical Document (PDF - 1097KB) | Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA |
| 12:15pm – 1:30pm | Lunch | On Your Own |
| 1:30pm – 2:15pm | Good Guidance Practices and CDER's Manual of Policies and Procedure (PDF - 206KB) | Nancy Derr Policy Analyst/Writer/Editor Office of Regulatory Policy CDER, FDA |
| 2:15pm – 3:00pm | Drug Development in the 21st Century: The Role of OND (PDF - 598KB) | Beth Duvall-Miller, B.S. Chem. Team Leader Regulatory Affairs Office of New Drugs CDER, FDA |
| 3:00pm – 3:15pm | Break | |
| 3:15pm – 4:00pm | Advisory Committees (PDF - 218KB) | Jayne Peterson Advisors and Consultants CDER, FDA |
| 4:00pm – 4:30pm | Skill Building for Reviewers in CDER (PDF - 456KB) | CDR Rita Shapiro, M.A., D.P.T. Office of Executive Programs Division of Training & Development CDER, FDA |
| 4:30pm – 5:00pm | CDER Public Transparency through WWW (PDF - 742KB) | Monica Unger, M.L.S. Web Project Manger Division of Information Services Office of Training and Communication CDER, FDA |
Tuesday, April 21, 2009
Review of New Molecular Entities
Moderator: Justina Molzon, M.S., Pharm, J.D.
Time | Topic | Presenter |
|---|---|---|
| 9:00am – 10:15am | Drug Review Process (PDF - 269KB) | Ann Farrell, M.D. Office of New Drugs Division of Drug Oncology Products CDER, FDA |
| 10:15am – 10:30am | Break | |
| 10:30am – 12:00pm | Regulatory Drug Review (PDF - 17KB) (panel) | Renmeet Grewal, Pharm. D. – Project Management/Moderator Audrey Gassman, M.D. – Med. Officer Angelica Dorantes, Ph.D. Daphne Ty Lin, Ph.D. – Statistician Amy L. Ellis, Ph.D. – Pharm. Tox. Cindy Kortepeter, Pharm. D. – Safety |
| 12:30pm – 1:00pm | Group Photo | |
| 1:00pm – 2:00pm | Lunch | On Your Own |
| 2:00pm – 2:45pm | Quality Review (Chemistry) (PDF - 277KB) | Norman R. Schmuff, Ph.D. Branch Chief Office of New Drug Quality Assessment Office of Pharmaceutical Science CDER, FDA |
| 2:45pm - 3:30pm | Quality Review (Biologics) (PDF - 1067KB) | Patrick Swann, Ph.D. Deputy Director Division of Monoclonal Antibodies Office of Biotechnology Products CDER, FDA |
| 3:30pm - 4:15pm | Special Reviews (Pediatrics) (PDF - 686KB) | Elizabeth Durmowicz, M.D. Team Leader Pediatric and Maternal Health Office of New Drugs CDER, FDA |
| 4:15pm – 4:30pm | Break | |
| 4:30pm – 5:30pm | Labeling Overview (PDF - 330KB) | Justina Molzon, M.S., Pharm, J.D. Associate Director International Programs CDER, FDA |
Wednesday, April 22, 2009
Review of Over-the-Counter and Generic Drugs
Moderator: Justina Molzon, M.S., Pharm, J.D.
Time | Topic | Presenter |
|---|---|---|
| 9:00am – 9:45am | Regulation of Over-the-Counter (OTC)Drugs (PDF - 553KB) | Leah Christl, Ph.D. Associate Director for Regulatory Affairs Office of Non-prescription Products CDER, FDA |
| 9:45am – 10:30am | Review of the OTC Drugs Team - Compliance Issues (PDF - 368KB) | Spencer Salis, Pharm. D. Regulatory Operations Officer (OTC) Division of New Drugs and Labeling Compliance Office of Compliance CDER FDA |
| 10:30am - 10:45am | Break | |
| 10:45am – 12:15pm | Overview of the Generic Drug Process (PDF - 1486KB) | Ted Sherwood Management Analyst Office of Pharmaceutical Science CDER, FDA |
| 12:15pm – 1:30pm | Lunch | On Your Own |
| 1:30pm – 3:00pm | ANDA Review Process, CMC Perspective (PDF - 449KB) | Suhas Patankar, Ph.D. Division of Chemistry Office of Generic Drugs Office of Pharmaceutical Sciences CDER, FDA |
| 3:00pm - 3:15pm | Break | |
| 3:15pm – 4:45pm | Bioequivalence Recommendations (PDF - 220KB) | Leah N. Williamson, Ph.D. Kuldeep R. Dhariwal, Ph.D. Division of Bioequivalence Office of Generic Drugs CDER, FDA |
Thursday, April 23, 2009
Compliance
Moderator: Justina Molzon, M.S., Pharm, J.D.
Time | Topic | Presenter |
|---|---|---|
| 9:00am – 9:30am | Compliance Overview (PDF - 133KB) | Jason Woo, M.D. Associate Director of Scientific and Medical Affairs Office of Compliance CDER, FDA |
| 9:30am – 11:00am | Division of Manufacturing and Product Quality (DMPQ), Office of Compliance | |
Monica Caphart, M.S. | ||
| Colleen Hoyt | ||
| Yumi Hiramine | ||
| Israel Santiago | ||
| Douglas Campbell, B.S. | ||
| 11:00am – 11:15am | DMPQ: Questions and Answers | |
| 11:15am - 11:30am | Break | |
| 11:30am – 12:15pm | Role of CDER in Bioresearch Monitoring Program (PDF - 272KB) | Connie Lewin, M.D. Medical Officer Division of Scientific Investigations Office of Compliance CDER, FDA |
| 12:15pm - 1:00pm | Bioequivalence and Good Laboratory Practice (PDF - 123KB) | Jacqueline O'Shaughnessy, Ph.D. Pharmacologist Division of Scientific Investigations Office of Compliance CDER, FDA |
| 1:00pm - 2:00pm | Lunch | On Your Own |
| 2:00pm – 3:30pm | Panel: Division of New Drugs and Labeling, Office of Compliance, CDER, FDA (PDF - 1080KB) | |
| Kathleen R. Anderson, Pharm. D. | |
| Elizabeth Miller, Pharm. D. | |
| Karen Rothschild, Esq. | |
| Huascar Batista, M.P.H Team Leader, Imports Exports Team | |
| Sudha Shukla, Pharm. D. | |
| 3:30pm - 3:45pm | Break | |
| 3:45pm – 5:00pm | Compliance Risk Management and Surveillance (PDF - 365KB) | John Coburn and |
Friday, April 24, 2009
Postmarketing
Moderator: Justina Molzon, M.S., Pharm, J.D.
Time | Topic | Presenter |
|---|---|---|
| 9:00am – 10:00am | Overview of Drug Safety (PDF - 282KB) | Gerald Dal Pan, M.D. M.H.S. Director Office of Surveillance and Epidemiology CDER, FDA |
| 10:00am - 10:15am | Break | |
| 10:15am – 11:15am | Overview of Drug Safety | Gerald Dal Pan, M.D. M.H.S. Director Office of Surveillance and Epidemiology CDER, FDA |
| 11:15am - 1:00pm | Lunch | On Your Own |
| 1:00pm – 1:45pm | Drug Marketing, Advertising, and Communications (PDF - 1452KB) | Barbara Chong, Pharm.D., BCPS Team Leader Division of Drug Marketing, Advertising, and Communications Office of Medical Policy CDER, FDA |
| 1:45pm – 2:30pm | Medical Errors (PDF - 3080KB) | Denise Toyer, Pharm. D. Division of Medication Errors Prevention and Analysis Office of Surveillance and Epidemiology CDER, FDA |
| 2:30pm – 3:00pm | FDA on WWW Wrap-up | Monica Unger, M.L.S. Web Project Manager Division of Information Services Office of Training and Communications CDER, FDA |
| 3:00pm – 3:30pm | Certificate Presentation and Review of the Contents on the Flash Drive; Farewell |
Registration information and requests should be sent to CDERForum@fda.hhs.gov. As a reminder, the CDER Forum is intended for international drug regulatory authorities, and registration from non drug regulatory authorities will not be honored.
Please include the following information about the proposed attendee, as well as the required security form :
- Name
- Position
- Title
- Country and Drug Regulatory Authority
- Address
- Phone
- Completed security form
For further information, contact:
Justina A. Molzon, MS Pharm, JD
Associate Director for International Programs
Center for Drug Evaluation and Research
United States Food and Drug Administration
U.S. Department of Health and Human Services
CDERForum@fda.hhs.gov
