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CDER Forum for International Drug Regulatory Authorities, October 6 - 10, 2008, Rockville, MD

   



 Final Program


Monday, October 6, 2008
Overview of Process and Structure


 
8:30am – 9:00amRegistration
9:00am - 12:30 pm Welcome and IntroductionJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
 FDA CDER in the International CommunityJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
 ICH and the Common Technical DocumentJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
 Good Review PracticesJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
12:30pm – 1:30pmLunchOn Your Own
1:30pm – 2:15pmCDER Public Transparency through the wwwPaul Stauffer
Web Project Manager
Division of Information Services
Office of Training and Communications, CDER, FDA
2:15pm – 3:00pmGood Guidance Practices and CDER’s Manual of Policies and ProceduresNancy Derr
Writer/Editor/Policy Analyst
Office of Regulatory Policy
CDER, FDA
3:00pm – 3:15pmBreak
3:15pm – 4:00pmThe Office of New DrugsBeth Duvall-Miller
Team Leader, Regulatory Affairs Team
Office of New Drugs, CDER, FDA
4:15pm - 4:45pmAdvisory CommitteesJayne Peterson
Deputy Director
Advisors and Consultants Staff
Office of Executive Programs
CDER, FDA
4:45pm – 5:15pmDrug Review and Related Activities in the United StatesCatherine Chew, Pharm.D.
Division of Drug Information
Office of Training and Communications
CDER, FDA
5:30m Adjourn; Moderator: Justina Molzon

Tuesday, October 7, 2008
Review of New Molecular Entities


 
8:30am – 8:45amWelcomeJustina A. Molzon, M.S. Pharm., J.D.
Associate Director, International Programs, CDER, FDA
9:00am – 10:25amDrug Review Process OverviewRobert Kane, MD, FACP
Medical Officer
Division of Drug Oncology Products
Office of Oncology Drug Products
Office of New Drugs, CDER, FDA
10:25am – 10:30amBreak
10:30am – 11:15amLabeling OverviewJeanne Delasko
Label Initiatives Specialist
Office of New Drugs, CDER, FDA
11:15am – 11:20amPhoto
11:25am – 11:35amQuestionsJeanne Delasko
Label Initiatives Specialist
Office of New Drugs, CDER, FDA
11:35am – 1:00pmLunchOn Your Own
1:00pm – 2:00pmQuality Review (Chemistry)Stephen Miller
Pharmaceutical Assessment Lead,
Division of PreMarketing Assessment II,
Office of New Drug Quality Assessment,
Office of Pharmaceutical Science, CDER, FDA
2:00pm – 2:50pmSpecialty Reviews – BiologicsPatrick Swann, Ph.D.
Deputy Director
Division of Monoclonal Antibodies
Office of Biotechnology Products
CDER, FDA
2:50pm – 3:25pmSpecialty Reviews – PediatricsHari Sachs, M.D.
Team Leader, Medical Officer, Pediatric and Maternal Health Staff, Immediate Office, Office of New Drugs, CDER, FDA
3:25pm – 3:35pmBreak
3:35pm – 5:50pmSafety and Efficacy Review Panel of DisciplinesDiscipline 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
 
  • 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
 
  • Safety Evaluator
Cindy Kortepeter, Pharm.D.
Division of Pharmacovigilance, 
Office of Surveillance and Epidemiology, CDER, FDA

Wednesday, October 8, 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 10:40amRegulation of Over-The-Counter Drugs

Leah Christl, Ph.D.,
Associate Director for Regulatory Affairs, Office of Nonprescription Products, Office of New Drugs, CDER, FDA

Robert Heller
Team Leader
Division of New Drugs and Labeling Compliance
Office of Compliance, CDER, FDA

10:40am – 10:50amBreak
10:50am –12:40pmOverview of the Generic Drug ProcessTed Sherwood
Management Analyst
Office of Pharmaceutical Science CDER, FDA
12:40pm – 1:45pmLunchOn Your Own
1:50pm – 2:55pmChemistrySuhas Patankar, Ph.D.
Division of Chemistry III
Office of Generic Drugs
Office of Pharmaceutical Sciences CDER, FDA
2:55pm – 4:30pmBioEquivalence

Partha Chandaroy, Ph.D.
Division of Bioequivalence
Office of Generic Drugs, CDER, FDA

Kuldeep Dhariwal, Ph.D.
Division of Bioequivalence
Office of Generic Drugs

4:30pm – 5:00pmTraining ReviewersRita Shapiro
Division of Training and Development
Office of Training and Communications
CDER, FDA
Moderator: Mary Kremzner

Thursday, October 9, 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 OverviewJason Woo, M.D.
Associate Director of Scientific and Medical Affairs
Office of Compliance, CDER, FDA
9:30am – 11:05amDrug Manufacturing and Product QualityNicholas Buhay
Deputy Director
Division of Manufacturing & Product Quality
Office of Compliance
Center for Drug Evaluation & Research
11:05am – 11:15amBreak
11:15am – 12:50pm

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
Elizabeth Miller, Pharm. D.
Pharmacist - Acting Team Leader, Division of New Drugs and Labeling Compliance
Office of Compliance, CDER, FDA
 
  • New Drugs and Labeling
Karen Rothschild, Esq.
Regulatory Counsel, Division of New Drugs and Labeling Compliance
Office of Compliance, CDER, FDA
 
  • Imports Exports
Huascar Batista, M.P.H
Consumer Safety Officer, Division of New Drugs and Labeling Compliance
Office of Compliance, CDER, FDA
 
  • Compounding
Stanley Shepperson, Pharm. D.
Regulatory Operations Officer, Compounding Team, Division of New Drugs and Labeling Compliance
Office of Compliance, CDER, FDA
12:50pm – 1:35pmLunch
1:35pm – 2:10pmScientific InvestigationsConstance Lewin, MD, MPH
Branch Chief, Good Clinical Practice Branch 1, Division of Scientific Investigations, Office of Compliance, CDER, FDA
2:10pm – 3:10pmInspectional ProcessDouglas A. Campbell
Compliance Officer
CDER / Office of Compliance
Division of Manufacturing and Product Quality
International Compliance Team
3:10pm – 3:20pmBreak
3:20pm – 4:30pmCompliance Risk Management and SurveillanceH. Gregg Claycamp, Ph.D.
Director (Acting)
Division of Compliance Risk Management and Surveillance
Office of Compliance, CDER, FDA

Friday, October 10, 2008
Postmarketing


 
9:00am – 9:15amWelcomeJustina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
9:05am -10:25amCommunicating Drug SafetyPaul Seligman, MD., M.P.H.
Associate Director for Safety Policy and Communication, Office Of The Center Director CDER, FDA
10:25am – 10:40amBreak
10:40am - 11:30amOverview of Drug SafetySkip Francis
Office of Surveillance and Epidemiology, CDER, FDA
11:45am – 1:00pmLunch
1:00pm – 1:20pmHand out certificates and review contents of CD 
1:20pm – 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 – 2:25pmBreak
2:25pm – 3:00pmMedication ErrorsDenise Toyer
Division of Medication Errors and Technical Support
Office of Surveillance and Epidemiology, CDER, FDA 
3:10pm – 3:30pmWWW Wrap upMonica 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