• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

CDER Forum for International Drug Regulatory Authorities, April 14 - 18, 2008, Rockville, MD

   



 Final Program and Presentations


Monday, April 14, 2008
Overview of Process and Structure


 
8:30am – 9:00amRegistration
9:00am – 9:10amWelcome and Introduction [PDF]Justina 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
9:30am – 10:30amCDER's Center DirectorJanet Woodcock, M.D.
Acting Director
CDER, FDA
10:30am – 11:30amIntroduction of Countries Attending ForumJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
11:30am – 12:30pmDrug Review and Related Activities in the United States [PDF]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 Procedures [PDF]Nancy Derr
Writer/Editor/Policy Analyst
Office of Regulatory Policy
CDER, FDA
2:00pm – 2:30pmGood Review Practices [PDF]Howard D. Chazin, M.D., M.B.A.
Medical Officer
Guidance and Policy Team
Office of New Drugs
CDER, FDA
2:30pm – 3:15pmOverview of the Office of New Drugs [PDF]Grace Carmouze
Lead Project Management Officer
Immediate Office
Office of New Drugs
CDER, FDA
3:15pm – 3:45pmEthicsVincent R. Tolino
Director, Ethics and Integrity Staff
Office of Management Programs
Office of Management
Office of the Commissioner, FDA
3:45pm – 4:00pmBreak
4:00pm – 4:30pmICH and the Common Technical Document [PDF]Justina 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, April 15, 2008
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 [PDF]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 [PDF]Jeanne Delasko
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.
Associate Director for Regulatory Affairs
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 IV
Office Of Biostatistics
Office of Translational Sciences
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 - Biologics [PDF]Patrick Swann, Ph.D.
Deputy Director
Division of Monoclonal Antibodies
Office of Biotechnology Products
CDER, FDA
3:45pm – 4:15pmSpecialty Reviews - Pediatrics [PDF]Hari Sachs, M.D.
Medical Officer
Pediatric and Maternal Health Staff
Immediate Office
Office of New Drugs
CDER, FDA

Wednesday, April 16, 2008
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 [PDF]Leah Christl, Ph.D.
Associate Director for Regulatory Affairs
Office of Nonprescription Products
Office of New Drugs
CDER, FDA
10:30am – 10:45amBreak
10:45am – 12:15pmOverview of the Generic Drug Process [PDF]Ted Sherwood
Management Analyst
Office of Pharmaceutical Science
CDER, FDA
12:15pm – 1:45pmLunchOn Your Own
1:45pm – 2:15pmChemistry [PDF]Dr. Suhas Patankar
Chemist
Division of Chemistry III
Office of Generic Drugs
Office of Pharmaceutical Sciences
CDER, FDA
2:15pm – 2:45pmBioEquivalence [PDF]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 Support [PDF]Gary M. Gensinger, M.B.A.
Director
Regulatory Review Support Staff
Office of Business Process Support
CDER, FDA
4:00pm – 4:30pmTraining Reviewers [PDF]Dorothy C. Ballmann, M.S.
Division of Training and Development
Office of Training and Communications
CDER, FDA
Moderator: Mary Kremzner

Thursday, April 17, 2008
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 Overview [PDF]Jason Woo, M.D.
Associate Director of Scientific and Medical Affairs
Office of Compliance
CDER, FDA
9:30am – 10:30amNew Drugs and Labeling Compliance 
 Kathleen R. Anderson, Pharm. D.
Deputy Director
Division of New Drugs and Labeling Compliance
Office of Compliance
CDER, FDA
 
  • Internet and Health Fraud
Elizabeth Miller, Pharm.D.
Pharmacist
Division of New Drugs and Labeling Compliance
Office of Compliance
CDER, FDA
 
  • New Drugs and Labeling
Meghan Murphy, Ph.D.
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 Quality [PDF]Karen Takahashi
Division of Manufacturing and Product Quality
Office of Compliance
CDER, FDA
11:45am – 1:00pmLunch
1:00 – 2:00pmScientific Investigations [PDF]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 Practices [PDF]Douglas A. Campbell
Compliance Officer
Division of Manufacturing and Product Quality
Office of Compliance
International Compliance Team
CDER, FDA
2:45pm – 3:00pmBreak
3:00pm – 4:00pmCompliance Risk Management and Surveillance [PDF]H. Gregg Claycamp, Ph.D.
Director (Acting)
Division of Compliance Risk Management and Surveillance
Office of Compliance
CDER, FDA

Friday, April 18, 2008
Postmarketing


 
9:00am – 9:15amWelcomeJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
9:15am – 10:15amCommunicating Drug Safety [PDF]Paul Seligman, M.D., 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 [PDF]Kathleen Frost
Office of Surveillance and Epidemiology
CDER, FDA
11:45am – 1:15pmLunch
1:15pm – 2:15pmDrug Marketing, Advertising, and Communications [PDF]Barbara 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 CDER [PDF]Monica Unger, M.L.S.
Web Project Manager
Division of Information Services
Office of Training and Communications
CDER, FDA
2:45pm – 3:15pmMedication Errors [PDF]Denise Toyer
Division of Medication Errors and Technical Support
Office of Surveillance and Epidemiology
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