CDER Forum for International Drug Regulatory Authorities: September 25

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FDA/Center for Drug Evaluation and Research

Center for Drug Evaluation and Research, U.S. Food and Drug Administration

CDER Forum for International Drug Regulatory Authorities
September 25 - 28, 2006
Rockville, Maryland

A program pamphlet and overview are also available in PDF format.

Final Program and Presentations
Registration Information
Contact Information

Final Program and Presentations

Monday, September 25, 2006 Overview of Process and Structure
9:00am - 9:15am	Welcome and Introduction	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA
9:15am - 9:45am	FDA in the International Community	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA Beverly Corey, DVM Director International Relations Staff Office of International Programs Office of the Commissioner, FDA
9:45am - 10:30am	CDER's Center Director	Steven K. Galson Director CDER, FDA
10:30am - 11:00am	Break
11:00am - 12:00pm	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
12:00pm - 1:30pm	Lunch
1:30pm - 2:15pm	Advisory Committees	Igor Cerny, Pharm.D. Director Advisors and Consultants Staff Office of Executive Programs CDER, FDA
2:15pm - 3:15pm	Drug Review Process Overview	Dena Hixon, M.D. Associate Director for Medical Affairs Office of Generic Drugs Office of Pharmaceutical Science CDER, FDA
3:15pm - 3:30pm	Break
3:30pm - 3:50pm	Ombudsman	Warren Rumble Ombudsman CDER, FDA
3:50pm - 4:15pm	Training Reviewers	Janice Newcomb Director Division of Training and Development Office of Training and Communications CDER, FDA
4:15pm - 5:00pm	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
Tuesday, September 26, 2006 Application Review
9:00am - 9:15am	Welcome	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA
9:15am - 9:30am	Good Guidance Practices	Nancy Derr Writer/Editor/Policy Analyst Office of Regulatory Policy CDER, FDA
9:30am - 10:00am	Good Review Practices	Howard D. Chazin, M.D., M.B.A Medical Officer Guidance and Policy Team Office of New Drugs CDER, FDA
10:00am - 11:00am	Overview of the Office of New Drugs	Kim Colangelo Associate Director for Regulatory Affairs Office of New Drugs CDER, FDA
11:00am - 11:15am	Break
11:15am - 12:15pm	Labeling	Jeanne Delasko Label Initiatives Specialist Office of New Drugs CDER, FDA
12:15pm - 1:45pm	Lunch
1:45pm - 2:00pm	Photo
2:00pm - 3:30pm	Panel of Discipline Roles	Discipline Panel
3:30pm - 3:45pm	Break
3:45pm - 4:25pm	Specialty Reviews - Biologics	David Ross Associate Director For Regulatory Science Office Of Oncology Drug Products Office Of New Drugs CDER, FDA
4:25pm - 4:45pm	Specialty Reviews - Pediatrics - US	Jean Temeck, M.D. Acting Medical Team Leader Pediatric and Maternal Health Staff Immediate Office Office of New Drugs, FDA Rosemary Addy, M.H.S. Regulatory Health Project Manager Pediatric and Maternal Health Staff Office of New Drugs CDER, FDA
4:45pm - 5:15pm	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
Wednesday, September 27, 2006 Compliance: Good Clinical Practices (GCP), Good Manufacturing Practices (GMP)
9:00am - 9:05am	Welcome	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA
9:05am - 9:20am	Compliance Overview	Deborah M. Autor, Esq. Director Office of Compliance CDER, FDA
9:20am - 10:15am	New Drugs and Labeling Compliance	Kathleen R. Anderson, Pharm. D. Acting Director Division of New Drugs and Labeling Compliance Office of Compliance CDER, FDA
	Internet and Health Fraud Team	Linda E. Silvers, DVM, MPH Acting Associate Director Division of New Drugs and Labeling Compliance Office of Compliance CDER, FDA
	New Drugs and Labeling	John P. Loh Team Leader New Drugs and Labeling Team Division of New Drugs and Labeling Compliance Office of Compliance CDER, FDA
	OTC Team	Robert A. Eshelman OTC Drugs Team Division of New Drugs and Labeling Compliance Office of Compliance CDER, FDA
	Imports, Exports and PDMA Team	Ada Irizarry Team Leader Import-Export Team Division of New Drugs and Labeling Compliance Office of Compliance CDER, FDA
	Compounding Team	Samia M. Nasr, R.Ph., M.S. Team Leader Compounding Team Division of New Drugs and Labeling Compliance HFD-317 Office of Compliance CDER, FDA
10:15am - 10:30am	Break
10:30am - 11:30am	Drug Manufacturing and Product Quality	Grace E. McNally Acting Deputy Division Director Drug Manufacturing and Product Quality Office of Compliance CDER, FDA
11:30am - 1:00pm	Lunch
1:00pm - 2:00pm	Compliance Risk Management and Surveillance	John W. Gardner, MD, DrPH Director, Div. Compliance Risk Management & Surveillance Office of Compliance CDER, FDA
2:00pm - 3:00pm	Scientific Investigations	Constance Lewin, MD, MPH Branch Chief, Good Clinical Practice Branch 1 Division of Scientific Investigations Office of Compliance CDER, FDA
3:00pm - 3:15pm	Break
3:15pm - 4:00pm	Inspectional Process and Good Laboratory Practices	Ruark Lanham Investigator / Program Expert Division of Field Investigations Office of Regional Operations Office of Regulatory Affairs, FDA
Thursday, September 28, 2006 Pharmocovigilance and Generic Drugs
9:00am - 9:15am	Welcome	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA
9:15am - 10:30am	Overview of Drug Safety (Dal Pan)	Gerald Dal Pan, M.D. Director Office of Surveillance and Epidemiology CDER, FDA
10:30am - 11:00am	Medication Errors	Denise Toyer Deputy Director Division of Medication Errors and Technical Support Office of Drug Safety CDER, FDA
11:00am - 11:15am	Break
11:15am - 12:15pm	Drug Marketing, Advertising, and Communications	Marci Kiester, Pharm.D. LCDR, United States Public Health Service Group Leader Division of Drug Marketing, Advertising, and Communications Office of Medical Policy CDER, FDA
12:15pm - 1:45pm	Lunch
1:45pm - 2:15pm	Public Service Campaigns	John Friel, J.D. Deputy Director Office of Training and Communications CDER, FDA
2:15pm - 3:00pm	Overview of the Generic Drug Process	Ted Sherwood Management Analyst Office of Pharmaceutical Science CDER, FDA
3:00pm - 3:30pm	Chemistry	Richard Adams Deputy Director Division of Chemistry II Office of Generic Drugs Office of Pharmaceutical Sciences CDER, FDA
3:30pm - 3:45pm	Break
3:45pm - 4:30pm	BioEquivalence	Shirley K. Lu, Ph.D. Division of Bioequivalence Office of Generic Drugs CDER, FDA Barbara M. Davit, J.D., Ph.D. Deputy Director, Division of Bioequivalence Office of Generic Drugs
4:30pm - 5:00pm	Web Developments at CDER	Monica Unger, M.L.S. Web Project Manager Division of Information Services Office of Training and Communications 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

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Date created: June 15, 2006, updated April 6, 2007