CDER Forum for International Drug Regulatory Authorities, April 14 - 18, 2008, Rockville, MD

   

• Final Program and Presentations
• Registration Information
• Contact Information

 Final Program and Presentations

Monday, April 14, 2008 Overview of Process and Structure
8:30am – 9:00am	Registration
9:00am – 9:10am	Welcome and Introduction [PDF]	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA
9:10am – 9:15am	FDA CDER in the International Community	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA
9:15am – 9:30am	Introduction of FDA's Office of International Programs	Murray M. Lumpkin, M.D. Deputy Commissioner for International and Special Programs Office of the Commissioner/OIP
9:30am – 10:30am	CDER's Center Director	Janet Woodcock, M.D. Acting Director CDER, FDA
10:30am – 11:30am	Introduction of Countries Attending Forum	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA
11:30am – 12:30pm	Drug Review and Related Activities in the United States [PDF]	Mary E. Kremzner, Pharm.D. Deputy Director Division of Drug Information Office of Training and Communications CDER, FDA
12:30pm – 1:30pm	Lunch	On Your Own
1:30pm – 2:00pm	Good Guidance Practices and CDER's Manual of Policies and Procedures [PDF]	Nancy Derr Writer/Editor/Policy Analyst Office of Regulatory Policy CDER, FDA
2:00pm – 2:30pm	Good Review Practices [PDF]	Howard D. Chazin, M.D., M.B.A. Medical Officer Guidance and Policy Team Office of New Drugs CDER, FDA
2:30pm – 3:15pm	Overview of the Office of New Drugs [PDF]	Grace Carmouze Lead Project Management Officer Immediate Office Office of New Drugs CDER, FDA
3:15pm – 3:45pm	Ethics	Vincent R. Tolino Director, Ethics and Integrity Staff Office of Management Programs Office of Management Office of the Commissioner, FDA
3:45pm – 4:00pm	Break
4:00pm – 4:30pm	ICH and the Common Technical Document [PDF]	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA
4:30pm – 5:00pm	Advisory Committees	Igor Cerny, Pharm.D. Director Advisors and Consultants Staff Office of Executive Programs CDER, FDA
Moderator: Justina Molzon
Tuesday, April 15, 2008 Review of New Molecular Entities
8:30am – 8:45am	Welcome	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA
8:45am – 9:45am	Drug Review Process Overview [PDF]	Ramzi Dagher Lead Medical Officer Division of Drug Oncology Products Office of Oncology Drug Products Office of New Drugs CDER, FDA
9:45am – 10:00am	Break
10:00am – 11:00am	Labeling Overview [PDF]	Jeanne Delasko Label Initiatives Specialist Office of New Drugs CDER, FDA
11:00am – 11:30am	Photo
11:30am – 1:00pm	Lunch	On Your Own
1:00pm – 2:45pm	Panel of Discipline Roles and Review Templates	Discipline Panel
	Panel Moderator and Project Manager	Leah Christl, Ph.D. Associate Director for Regulatory Affairs Office of Nonprescription Products Office of New Drugs CDER, FDA
	Medical Officer	Audrey Gassman, Ph.D Medical Officer Division of Reproductive and Urologic Drug Products Office of Drug Evaluation 3 CDER, FDA
	Chemist	Norman Schmuff Branch Chief Branch IV Division of Pre-Marketing Assessment II Office of New Drug Quality Assessment Office of Pharmaceutical Science CDER, FDA
	Clinical Pharmacologist	Angelica Dorantes Division of Clinical Pharmacology I Office of Clinical Pharmacology Office of Translational Sciences CDER, FDA
	Statistician	Daphne Ty Lin, Ph.D. Deputy Director Division Of Biometrics IV Office Of Biostatistics Office of Translational Sciences CDER, FDA
	Pharmacologist Toxicologist	Amy L. Ellis, Ph.D. Division of Anti-Infective and Ophthalmology Products Office of Antimicrobial Products Office of New Drugs CDER, FDA
	Drug Risk Evaluation	Susan Lu Team Leader Division of Drug Risk Evaluation Office of Surveillance and Epidemiology CDER, FDA
2:45pm – 3:00pm	Break
3:00pm – 3:45pm	Specialty Reviews - Biologics [PDF]	Patrick Swann, Ph.D. Deputy Director Division of Monoclonal Antibodies Office of Biotechnology Products CDER, FDA
3:45pm – 4:15pm	Specialty Reviews - Pediatrics [PDF]	Hari Sachs, M.D. Medical Officer Pediatric and Maternal Health Staff Immediate Office Office of New Drugs CDER, FDA
Wednesday, April 16, 2008 Review of OTC and Generics
9:00am – 9:05am	Welcome	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA
9:05am – 10:30am	Regulation of Over-the-Counter Drugs [PDF]	Leah Christl, Ph.D. Associate Director for Regulatory Affairs Office of Nonprescription Products Office of New Drugs CDER, FDA
10:30am – 10:45am	Break
10:45am – 12:15pm	Overview of the Generic Drug Process [PDF]	Ted Sherwood Management Analyst Office of Pharmaceutical Science CDER, FDA
12:15pm – 1:45pm	Lunch	On Your Own
1:45pm – 2:15pm	Chemistry [PDF]	Dr. Suhas Patankar Chemist Division of Chemistry III Office of Generic Drugs Office of Pharmaceutical Sciences CDER, FDA
2:15pm – 2:45pm	BioEquivalence [PDF]	Partha Chandaroy, Ph.D. Division of Bioequivalence Office of Generic Drugs CDER, FDA Kuldeep Dhariwal, Ph.D. Division of Bioequivalence Office of Generic Drugs CDER, FDA
3:15pm – 3:30pm	Break
3:30pm – 4:00pm	The Role of CDER's Office of Business Process Support [PDF]	Gary M. Gensinger, M.B.A. Director Regulatory Review Support Staff Office of Business Process Support CDER, FDA
4:00pm – 4:30pm	Training Reviewers [PDF]	Dorothy C. Ballmann, M.S. Division of Training and Development Office of Training and Communications CDER, FDA
Moderator: Mary Kremzner
Thursday, April 17, 2008 Good Manufacturing Practice and Good Clinical Practice
9:00am – 9:15am	Welcome	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA
9:15am – 9:30am	Compliance Overview [PDF]	Jason Woo, M.D. Associate Director of Scientific and Medical Affairs Office of Compliance CDER, FDA
9:30am – 10:30am	New Drugs and Labeling Compliance
	Overview [PDF]	Kathleen R. Anderson, Pharm. D. Deputy Director Division of New Drugs and Labeling Compliance Office of Compliance CDER, FDA
	Internet and Health Fraud	Elizabeth Miller, Pharm.D. Pharmacist Division of New Drugs and Labeling Compliance Office of Compliance CDER, FDA
	New Drugs and Labeling	Meghan Murphy, Ph.D. Consumer Safety Officer Division of New Drugs and Labeling Compliance Office of Compliance CDER, FDA
	Over-the-Counter Drugs	Robert Heller Team Leader Division of New Drugs and Labeling Compliance Office of Compliance CDER, FDA
	Imports Exports	Huascar Batista, M.P.H. Division of New Drugs and Labeling Compliance Office of Compliance CDER, FDA
	Compounding	Samia M. Nasr, R.Ph., M.S. Team Leader Compounding Team Division of New Drugs and Labeling Compliance Office of Compliance CDER, FDA
10:30am – 10:45am	Break
10:45am – 11:45am	Drug Manufacturing and Product Quality [PDF]	Karen Takahashi Division of Manufacturing and Product Quality Office of Compliance CDER, FDA
11:45am – 1:00pm	Lunch
1:00 – 2:00pm	Scientific Investigations [PDF]	Sherbet Samuels, R.N., M.P.H. Good Clinical Practice Branch 1 Division of Scientific Investigations Office of Compliance CDER, FDA
2:00pm – 2:45pm	Inspectional Process and Good Laboratory Practices [PDF]	Douglas A. Campbell Compliance Officer Division of Manufacturing and Product Quality Office of Compliance International Compliance Team CDER, FDA
2:45pm – 3:00pm	Break
3:00pm – 4:00pm	Compliance Risk Management and Surveillance [PDF]	H. Gregg Claycamp, Ph.D. Director (Acting) Division of Compliance Risk Management and Surveillance Office of Compliance CDER, FDA
Friday, April 18, 2008 Postmarketing
9:00am – 9:15am	Welcome	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA
9:15am – 10:15am	Communicating Drug Safety [PDF]	Paul Seligman, M.D., M.P.H. Associate Director for Safety Policy and Communication Office of the Center Director CDER, FDA
10:15am – 10:30am	Break
10:30am – 11:45am	Overview of Drug Safety [PDF]	Kathleen Frost Office of Surveillance and Epidemiology CDER, FDA
11:45am – 1:15pm	Lunch
1:15pm – 2:15pm	Drug Marketing, Advertising, and Communications [PDF]	Barbara Chong, Pharm.D., BCPS Team Leader Division of Drug Marketing, Advertising, and Communications Office of Medical Policy CDER, FDA
2:15pm – 2:45pm	Web Developments at CDER [PDF]	Monica Unger, M.L.S. Web Project Manager Division of Information Services Office of Training and Communications CDER, FDA
2:45pm – 3:15pm	Medication Errors [PDF]	Denise Toyer Division of Medication Errors and Technical Support Office of Surveillance and Epidemiology CDER, FDA

 

 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:

• Name
• Position
• Title
• Country and Drug Regulatory Authority
• Address
• Phone
• E-mail

 

 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