CDER Forum for International Drug Regulatory Authorities, April 20 - 24, 2009, Silver Spring, MD

   

• Final Program
• Registration Information
• Contact Information

 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
	Case Management (PDF - 307KB)	Monica Caphart, M.S.
	Manufacturer Assessment & Pre-approval (PDF - 155KB)	Colleen Hoyt
	International Compliance (PDF - 199KB)	Yumi Hiramine
	Recalls, Shortages, and Certificates (PDF - 456KB)	Israel Santiago
	Inspectional Process (PDF - 286KB)	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)
	Overview	Kathleen R. Anderson, Pharm. D. Deputy Director
	Internet and Health Fraud	Elizabeth Miller, Pharm. D. Pharmacist - Acting Team Leader Internet and Health Fraud Team
	New Drugs and Labeling	Karen Rothschild, Esq. Regulatory Counsel New Drugs and Labeling Team
	Imports Exports	Huascar Batista, M.P.H Team Leader, Imports Exports Team
	Pharmacy Compounding	Sudha Shukla, Pharm. D. Pharmacist, Compounding Team
3:30pm - 3:45pm	Break
3:45pm – 5:00pm	Compliance Risk Management and Surveillance (PDF - 365KB)	John Coburn and Suzanne Barone, Ph.D. Division of Compliance Risk Management and Surveillance

 

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

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
• E-mail
• 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