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

  



 

 Final Program and Presentations


Monday, April 16, 2007
Overview of Process and Structure


 
8:30am - 9:00amRegistration
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 
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 - 10:45amCDER's Center DirectorSteven K. Galson
Director
CDER, FDA
10:45am - 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 - 2:00pmGood Review Practices Howard D. Chazin, M.D., M.B.A
Medical Officer
Guidance and Policy Team
Office of New Drugs
CDER, FDA
2:00pm - 3:00pmDrug 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 - 3:15pmGood Guidance Practices Nancy Derr
Writer/Editor/Policy Analyst
Office of Regulatory Policy
CDER, FDA
3:15pm - 3:30pmICH and the Common Technical Document Justina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
3:30pm - 3:45pmBreak
3:45pm - 4:30pmAdvisory Committees Igor Cerny, Pharm.D.
Director
Advisors and Consultants Staff
Office of Executive Programs
CDER, FDA
4:30pm - 5:00pmTraining 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 - 9:15amWelcomeJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
9:15am - 10:15amOverview of the Office of New Drugs Grace Carmouze
Lead Project Management Officer
Immediate Office
Office of New Drugs
CDER, FDA
10:15am - 10:30amBreak
10:30am - 11:30pmLabeling Overview Jeanne Delasko
Label Initiatives Specialist
Office of New Drugs
CDER, FDA
11:30pm - 1:00pmLunch
1:00 - 1:15pmPhoto 
1:15pm - 3:15pmPanel of Discipline Roles and Review TemplatesDiscipline 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 - 3:30pmBreak
3:30pm - 4:15pmSpecialty Reviews - Biologics Glen Jones
Associate Director For Regulatory Affairs
Office Of Oncology Drug Products
Office Of New Drugs
CDER, FDA
4:15pm - 4:45Specialty 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 - 9:05amWelcomeJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
9:05 - 9:45amRegulation 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 - 10:45amOverview of the Generic Drug Process Ted Sherwood
Management Analyst
Office of Pharmaceutical Science
CDER, FDA
10:45am - 11:00amBreak
10:45am - 11:45amChemistry Ubrani Venkataram
Chemist
Division of Chemistry II
Office of Generic Drugs
Office of Pharmaceutical Sciences
CDER, FDA
11:45am - 1:15pmLunch
1:15pm - 2:30pmBioEquivalence 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 - 3:15pmEthicsVincent R. Tolino
Director
Ethics and Integrity Staff
Office of Management Programs
Office of Management
Office of the Commissioner, FDA
3:15pm - 3:30pmBreak
3:30pm - 4:15pmThe Role of CDER's Office of Business Process SupportGary 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 - 9:15amWelcomeJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
9:15am - 9:30amCompliance OverviewDeborah M. Autor, Esq.
Director
Office of Compliance
CDER, FDA
9:30am - 10:30amNew 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 - 10:45amBreak
10:45am - 11:45amDrug Manufacturing and Product Quality Grace E. McNally
Acting Deputy Division Director
Drug Manufacturing and Product Quality
Office of Compliance
CDER, FDA
11:45am - 1:00pmLunch
1:00 - 2:00pmScientific Investigations Constance Lewin, MD, MPH
Branch Chief
Good Clinical Practice Branch 1
Division of Scientific Investigations
Office of Compliance
CDER, FDA
2:00pm - 2:45pmInspectional 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 - 3:00pmBreak
3:00pm - 4:00pmCompliance 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 - 9:15amWelcomeJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
9:15am - 10:30amOverview of Drug Safety Gerald Dal Pan, M.D.
Director
Office of Surveillance and Epidemiology
CDER, FDA
10:30am - 11:00amMedication ErrorsDenise Toyer
Division of Medication Errors and Technical Support
Office of Drug Safety
CDER, FDA
11:00am - 12:00pmDrug 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 - 12:30pmWeb 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