CDER Forum for International Drug Regulatory Authorities, October 1 - 5, 2007, Rockville, MD

   

• Final Program and Presentations
• Registration Information
• Contact Information

 Final Program and Presentations

Monday, October 1, 2007 Overview of Process and Structure
8:30am - 9:00am	Registration
9:00am - 9:10am	Welcome and Introduction	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 CDER, FDA
9:30am - 10:00am	Introduction of Countries Attending Forum	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA
10:00am - 11:00am	CDER's Center Director	Steven K. Galson Director CDER, FDA
11:00am - 11:15am	Break
11:30am - 12:30pm	Drug Review and Related Activities in the United States	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	Nancy Derr Writer/Editor/Policy Analyst Office of Regulatory Policy CDER, FDA
2:00pm - 2:30pm	Good Review Practices	Howard D. Chazin, M.D., M.B.A Medical Officer Guidance and Policy Team Office of New Drugs CDER, FDA
2:30pm - 3:15pm	Ethics	Vincent R. Tolino Director, Ethics and Integrity Staff Office of Management Programs Office of Management Office of the Commissioner, FDA
3:15pm - 3:45pm	Ombudsman	Virginia Behr Ombudsman CDER, FDA
3:45pm - 4:00pm	Break
4:00pm - 4:30pm	ICH and the Common Technical Document	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, October 2, 2007 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	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	William Pierce, Pharm.D. 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. Regulatory Project Manager and Acting Chief Project Management Staff 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 III Office Of Biostatistics Office of Pharmacoepidemiology and Statistical Science CDER, FDA
	Drug Safety	Denise Toyer, Pharm.D., R.PH Deputy Director Division of Medication Errors and Technical Support Office of Drug Safety 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	Steve Kozlowski, M.D. Director Office of Biotechnology Products Office of Pharmaceutical Science CDER
3:45pm - 4:15pm	Specialty Reviews - Pediatrics	Amy Taylor, M.D. Medical Officer Pediatric and Maternal Health Staff Immediate Office Office of New Drugs CDER, FDA
4:15pm - 5:00pm	Overview of the Office of New Drugs	Grace Carmouze Lead Project Management Officer Immediate Office Office of New Drugs CDER, FDA
Wednesday, October 3, 2007 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	Leah Christl, Ph.D. Regulatory Project Manager and Acting Chief Project Management Staff 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	Ted Sherwood Management Analyst Office of Pharmaceutical Science CDER, FDA
12:15pm - 1:45pm	Lunch	On Your Own
1:45pm - 2:15pm	Chemistry	Dr. Suhas Patankar Chemist Division of Chemistry III Office of Generic Drugs Office of Pharmaceutical Sciences CDER, FDA
2:15pm - 2:45pm	BioEquivalence	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	Gary M. Gensinger, MBA Director Regulatory Review Support Staff Office of Business Process Support CDER, FDA
4:00pm - 4:30pm	Training Reviewers	Dorothy C. Ballmann M.S. Division of Training and Development Office of Training and Communications CDER, FDA
Moderator: Mary Kremzner
Thursday, October 4, 2007 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	Deborah M. Autor, Esq. Director Office of Compliance CDER, FDA
9:30am - 10:30am	New Drugs and Labeling Compliance
	Overview	Kathleen R. Anderson, Pharm. D. Deputy Director Division of New Drugs and Labeling Compliance Office of Compliance CDER, FDA
	Internet and Health Fraud	Linda Silvers, D.V.M., M.P.H. Team Leader Division of New Drugs and Labeling Compliance Office of Compliance CDER, FDA
	New Drugs and Labeling	Sakineh Walther, R.N. 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	Edwin Rivera Martinez Acting Deputy Division Director Drug Manufacturing and Product Quality Office of Compliance CDER, FDA
11:45am - 1:00pm	Lunch
1:00 - 2:00pm	Scientific Investigations	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	Edwin Rivera Martinez Acting Deputy Division Director Drug Manufacturing and Product Quality Office of Compliance CDER, FDA
2:45pm - 3:00pm	Break
3:00pm - 4:00pm	Compliance Risk Management and Surveillance	H. Gregg Claycamp, Ph.D. Director (Acting) Division of Compliance Risk Management and Surveillance Office of Compliance CDER, FDA
Friday, October 5, 2007 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	Paul Seligman, MD., 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	Kathleen Frost Office of Surveillance and Epidemiology CDER, FDA
11:45am - 1:15pm	Lunch
1:15pm - 2:15pm	Drug Marketing, Advertising, and Communications	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	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	Denise Toyer Division of Medication Errors and Technical Support Office of Drug Safety 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