CDER Forum for International Drug Regulatory Authorities, April 16 - 20, 2007, Rockville, MD

  

• Final Program and Presentations
• Registration Information
• Contact Information

 

 Final Program and Presentations

Monday, April 16, 2007 Overview of Process and Structure
8:30am - 9:00am	Registration
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  Introduction of Countries Attending Forum	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA Beverly Corey, DVM Staff Director Americas, Asia, Africa, Middle East Office of International Programs Office of the Commissioner, FDA
9:45am - 10:45am	CDER's Center Director	Steven K. Galson Director CDER, FDA
10:45am - 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 - 2:00pm	Good Review Practices	Howard D. Chazin, M.D., M.B.A Medical Officer Guidance and Policy Team Office of New Drugs CDER, FDA
2:00pm - 3:00pm	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
3:00pm - 3:15pm	Good Guidance Practices	Nancy Derr Writer/Editor/Policy Analyst Office of Regulatory Policy CDER, FDA
3:15pm - 3:30pm	ICH and the Common Technical Document	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA
3:30pm - 3:45pm	Break
3:45pm - 4:30pm	Advisory Committees	Igor Cerny, Pharm.D. Director Advisors and Consultants Staff Office of Executive Programs CDER, FDA
4:30pm - 5:00pm	Training Reviewers	Janice Newcomb Director Division of Training and Development Office of Training and Communications CDER, FDA
Tuesday, April 17, 2007 Review of New Molecular Entities
9:00am - 9:15am	Welcome	Justina A. Molzon, M.S. Pharm., J.D. Associate Director International Programs CDER, FDA
9:15am - 10:15am	Overview of the Office of New Drugs	Grace Carmouze Lead Project Management Officer Immediate Office Office of New Drugs CDER, FDA
10:15am - 10:30am	Break
10:30am - 11:30pm	Labeling Overview	Jeanne Delasko Label Initiatives Specialist Office of New Drugs CDER, FDA
11:30pm - 1:00pm	Lunch
1:00 - 1:15pm	Photo
1:15pm - 3:15pm	Panel of Discipline Roles and Review Templates	Discipline Panel
	Medical Officer	Lesley-Anne Furlong, MD Medical Officer Division of Reproductive and Urologic Drug Products Office of Drug Evaluation 3 CDER, FDA
	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
	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
	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
	Biologics	Steve Kozlowski, M.D. Director Office of Biotechnology Products Office of Pharmaceutical Science CDER
	Pharmacologist Toxicologist	Amy L. Ellis, Ph.D. Division of Anti-Infective and Ophthalmology Products Office of Antimicrobial Products Office of New Drugs CDER, FDA
3:15pm - 3:30pm	Break
3:30pm - 4:15pm	Specialty Reviews - Biologics	Glen Jones Associate Director For Regulatory Affairs Office Of Oncology Drug Products Office Of New Drugs CDER, FDA
4:15pm - 4:45	Specialty Reviews - Pediatrics	Jean Temeck, M.D. Medical Team Leader Pediatric and Maternal Health Staff Immediate Office Office of New Drugs CDER, FDA
Wednesday, April 18, 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
9:05 - 9:45am	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
9:45am - 10:45am	Overview of the Generic Drug Process	Ted Sherwood Management Analyst Office of Pharmaceutical Science CDER, FDA
10:45am - 11:00am	Break
10:45am - 11:45am	Chemistry	Ubrani Venkataram Chemist Division of Chemistry II Office of Generic Drugs Office of Pharmaceutical Sciences CDER, FDA
11:45am - 1:15pm	Lunch
1:15pm - 2:30pm	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
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 - 3:30pm	Break
3:30pm - 4:15pm	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
Thursday, April 19, 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	Ada Irizarry Team Leader Division of New Drugs and Labeling Compliance Office of Compliance CDER, FDA
	Compounding	Robert Kang, Pharm. D. Regulatory Operations Officer 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	Grace E. McNally 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	Constance Lewin, MD, MPH Branch Chief Good Clinical Practice Branch 1 Division of Scientific Investigations Office of Compliance CDER, FDA
2:00pm - 2:45pm	Inspectional Process and Good Laboratory Practices	Ruark Lanham Investigator / Program Expert Division of Field Investigations Office of Regional Operations Office of Regulatory Affairs, FDA
2:45pm - 3:00pm	Break
3:00pm - 4:00pm	Compliance Risk Management and Surveillance	John W. Gardner, MD, DrPH Director Div. Compliance Risk Management & Surveillance Office of Compliance CDER, FDA
Friday, April 20, 2007 Postmarketing
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	Gerald Dal Pan, M.D. Director Office of Surveillance and Epidemiology CDER, FDA
10:30am - 11:00am	Medication Errors	Denise Toyer Division of Medication Errors and Technical Support Office of Drug Safety CDER, FDA
11:00am - 12:00pm	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
12:00pm - 12:30pm	Web Developments at CDER	Monica Unger, M.L.S. Web Project Manager Division of Information Services Office of Training and Communications CDER, FDA
Location Note: Friday's session will be held at a different location.

 

 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