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

   

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


 

 Final Program and Presentations

Monday, September 25, 2006
Overview of Process and Structure
9:00am - 9:15amWelcome and IntroductionJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
9:15am - 9:45amFDA 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 - 10:30amCDER's Center DirectorSteven K. Galson
Director
CDER, FDA
10:30am - 11:00amBreak 
11:00am - 12:00pmDrug 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 - 1:30pmLunch 
1:30pm - 2:15pmAdvisory Committees Igor Cerny, Pharm.D.
Director
Advisors and Consultants Staff
Office of Executive Programs
CDER, FDA
2:15pm - 3:15pmDrug Review Process Overview Dena Hixon, M.D.
Associate Director for Medical Affairs
Office of Generic Drugs
Office of Pharmaceutical Science
CDER, FDA
3:15pm - 3:30pmBreak 
3:30pm - 3:50pmOmbudsman Warren Rumble
Ombudsman
CDER, FDA
3:50pm - 4:15pmTraining Reviewers Janice Newcomb
Director
Division of Training and Development
Office of Training and Communications
CDER, FDA
4:15pm - 5:00pmThe Role of CDER's Office of Business Process SupportGary M. Gensinger, MBA
Director
Regulatory Review Support Staff
Office of Business Process Support
CDER, FDA
Tuesday, September 26, 2006
Application Review
9:00am - 9:15amWelcomeJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
9:15am - 9:30amGood Guidance PracticesNancy Derr
Writer/Editor/Policy Analyst
Office of Regulatory Policy
CDER, FDA
9:30am - 10:00amGood Review Practices Howard D. Chazin, M.D., M.B.A
Medical Officer
Guidance and Policy Team
Office of New Drugs
CDER, FDA
10:00am - 11:00amOverview of the Office of New Drugs Kim Colangelo
Associate Director for Regulatory Affairs
Office of New Drugs
CDER, FDA
11:00am - 11:15amBreak 
11:15am - 12:15pmLabeling Jeanne Delasko
Label Initiatives Specialist
Office of New Drugs
CDER, FDA
12:15pm - 1:45pmLunch 
1:45pm - 2:00pmPhoto 
2:00pm - 3:30pmPanel of Discipline RolesDiscipline Panel
3:30pm - 3:45pmBreak 
3:45pm - 4:25pmSpecialty Reviews - BiologicsDavid Ross
Associate Director For Regulatory Science
Office Of Oncology Drug Products
Office Of New Drugs
CDER, FDA
4:25pm - 4:45pmSpecialty 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 - 5:15pmRegulation 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 - 9:05amWelcomeJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
9:05am - 9:20amCompliance OverviewDeborah M. Autor, Esq.
Director
Office of Compliance
CDER, FDA
9:20am - 10:15amNew 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 - 10:30amBreak 
10:30am - 11:30amDrug Manufacturing and Product QualityGrace E. McNally
Acting Deputy Division Director
Drug Manufacturing and Product Quality
Office of Compliance
CDER, FDA
11:30am - 1:00pmLunch 
1:00pm - 2:00pmCompliance Risk Management and Surveillance John W. Gardner, MD, DrPH
Director, Div. Compliance Risk Management & Surveillance
Office of Compliance
CDER, FDA
2:00pm - 3:00pmScientific Investigations Constance Lewin, MD, MPH
Branch Chief, Good Clinical Practice Branch 1
Division of Scientific Investigations
Office of Compliance
CDER, FDA
3:00pm - 3:15pmBreak 
3:15pm - 4:00pmInspectional Process and Good Laboratory PracticesRuark 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 - 9:15amWelcomeJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
9:15am - 10:30amOverview of Drug Safety (Dal Pan) Gerald Dal Pan, M.D.
Director
Office of Surveillance and Epidemiology
CDER, FDA
10:30am - 11:00amMedication ErrorsDenise Toyer
Deputy Director
Division of Medication Errors and Technical Support
Office of Drug Safety
CDER, FDA
11:00am - 11:15amBreak 
11:15am - 12:15pmDrug Marketing, Advertising, and CommunicationsMarci 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 - 1:45pmLunch 
1:45pm - 2:15pmPublic Service Campaigns John Friel, J.D.
Deputy Director
Office of Training and Communications
CDER, FDA
2:15pm - 3:00pmOverview of the Generic Drug Process Ted Sherwood
Management Analyst
Office of Pharmaceutical Science
CDER, FDA
3:00pm - 3:30pmChemistryRichard Adams
Deputy Director
Division of Chemistry II
Office of Generic Drugs
Office of Pharmaceutical Sciences
CDER, FDA
3:30pm - 3:45pmBreak 
3:45pm - 4:30pmBioEquivalenceShirley 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 - 5:00pmWeb 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