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

   



 Final Program and Presentations


Monday, October 1, 2007
Overview of Process and Structure


 
8:30am - 9:00amRegistration
9:00am - 9:10amWelcome and IntroductionJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
9:10am - 9:15amFDA CDER in the International CommunityJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
9:15am - 9:30amIntroduction of FDA's Office of International ProgramsMurray M. Lumpkin, M.D.
Deputy Commissioner for International and Special Programs
Office of the Commissioner/OIP
CDER, FDA
9:30am - 10:00amIntroduction of Countries Attending ForumJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
10:00am - 11:00amCDER's Center DirectorSteven K. Galson
Director
CDER, FDA
11:00am - 11:15amBreak
11:30am - 12:30pmDrug 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 - 1:30pmLunchOn Your Own
1:30pm - 2:00pmGood Guidance Practices and CDER’s Manual of Policies and ProceduresNancy Derr
Writer/Editor/Policy Analyst
Office of Regulatory Policy
CDER, FDA
2:00pm - 2:30pmGood Review Practices Howard D. Chazin, M.D., M.B.A
Medical Officer
Guidance and Policy Team
Office of New Drugs
CDER, FDA
2:30pm - 3:15pmEthicsVincent R. Tolino
Director, Ethics and Integrity Staff
Office of Management Programs
Office of Management
Office of the Commissioner, FDA
3:15pm - 3:45pmOmbudsman Virginia Behr
Ombudsman
CDER, FDA
3:45pm - 4:00pmBreak
4:00pm - 4:30pmICH and the Common Technical DocumentJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
4:30pm - 5:00pmAdvisory CommitteesIgor 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 - 8:45amWelcomeJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
8:45am - 9:45amDrug 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 - 10:00amBreak
10:00am - 11:00amLabeling Overview William Pierce, Pharm.D.
Label Initiatives Specialist
Office of New Drugs
CDER, FDA
11:00am - 11:30amPhoto
11:30am - 1:00pmLunchOn Your Own
1:00pm - 2:45pmPanel of Discipline Roles and Review TemplatesDiscipline 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 - 3:00pmBreak
3:00pm - 3:45pmSpecialty Reviews - BiologicsSteve Kozlowski, M.D.
Director
Office of Biotechnology Products
Office of Pharmaceutical Science
CDER
3:45pm - 4:15pmSpecialty Reviews - PediatricsAmy Taylor, M.D.
Medical Officer
Pediatric and Maternal Health Staff
Immediate Office
Office of New Drugs
CDER, FDA
4:15pm - 5:00pmOverview of the Office of New DrugsGrace Carmouze
Lead Project Management Officer
Immediate Office
Office of New Drugs
CDER, FDA

Wednesday, October 3, 2007
Review of OTC and Generics


 
9:00am - 9:05amWelcomeJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
9:05am - 10:30amRegulation 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 - 10:45amBreak
10:45am - 12:15pmOverview of the Generic Drug Process Ted Sherwood
Management Analyst
Office of Pharmaceutical Science
CDER, FDA
12:15pm - 1:45pmLunchOn Your Own
1:45pm - 2:15pmChemistry Dr. Suhas Patankar
Chemist
Division of Chemistry III
Office of Generic Drugs
Office of Pharmaceutical Sciences
CDER, FDA
2:15pm - 2:45pmBioEquivalence 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 - 3:30pmBreak
3:30pm - 4:00pmThe Role of CDER's Office of Business Process SupportGary M. Gensinger, MBA
Director
Regulatory Review Support Staff
Office of Business Process Support
CDER, FDA
4:00pm - 4:30pmTraining ReviewersDorothy 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 - 9:15amWelcomeJustina 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
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 - 10:45amBreak
10:45am - 11:45amDrug Manufacturing and Product QualityEdwin Rivera Martinez
Acting Deputy Division Director
Drug Manufacturing and Product Quality
Office of Compliance
CDER, FDA
11:45am - 1:00pmLunch
1:00 - 2:00pmScientific Investigations Sherbet Samuels, R.N., M.P.H
Good Clinical Practice Branch 1
Division of Scientific Investigations
Office of Compliance
CDER, FDA
2:00pm - 2:45pmInspectional Process and Good Laboratory PracticesEdwin Rivera Martinez
Acting Deputy Division Director
Drug Manufacturing and Product Quality
Office of Compliance
CDER, FDA
2:45pm - 3:00pmBreak
3:00pm - 4:00pmCompliance Risk Management and SurveillanceH. 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 - 9:15amWelcomeJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
9:15am - 10:15amCommunicating Drug SafetyPaul Seligman, MD., M.P.H.
Associate Director for Safety Policy and Communication
Office Of The Center Director
CDER, FDA
10:15am - 10:30amBreak
10:30am - 11:45amOverview of Drug Safety Kathleen Frost
Office of Surveillance and Epidemiology
CDER, FDA
11:45am - 1:15pmLunch
1:15pm - 2:15pmDrug Marketing, Advertising, and CommunicationsBarbara Chong, Pharm.D., BCPS
Team Leader
Division of Drug Marketing, Advertising, and Communications
Office of Medical Policy
CDER, FDA
2:15pm - 2:45pmWeb Developments at CDERMonica Unger, M.L.S.
Web Project Manager
Division of Information Services
Office of Training and Communications
CDER, FDA
2:45pm - 3:15pmMedication ErrorsDenise 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