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CDER Forum for International Drug Regulatory Authorities, April 20 - 24, 2009, Silver Spring, MD

   


 Monday, April 20, 2009  

 Overview of Process and Structure

Time

Topic

Presenter

8:30am – 9:00amRegistration 
9:00am – 10:00amWelcome and Introduction (PDF - 2473KB)Justina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
10:00am – 10:30am

FDA’s International Program (PDF - 268KB)

 

Walter Batts
Deputy Director
Office of International Programs
Office of the Commissioner
FDA
10:30am – 10:45amBreak 
10:45am – 11:15amRole of CDER (PDF - 1753KB)Mary E. Kremzner, Pharm.D.
Associate Director
Division of Drug Information
CDER, FDA
11:15am - 12:15pmICH and the Common Technical Document (PDF - 1097KB)Justina A. Molzon, M.S. Pharm., J.D.
Associate Director
International Programs
CDER, FDA
12:15pm – 1:30pmLunchOn Your Own
1:30pm – 2:15pmGood Guidance Practices and CDER's Manual of Policies and Procedure (PDF - 206KB)Nancy Derr
Policy Analyst/Writer/Editor
Office of Regulatory Policy
CDER, FDA
2:15pm – 3:00pmDrug Development in the 21st Century: The Role of OND (PDF - 598KB)Beth Duvall-Miller, B.S. Chem.
Team Leader Regulatory Affairs
Office of New Drugs
CDER, FDA
3:00pm – 3:15pmBreak 
3:15pm – 4:00pmAdvisory Committees (PDF - 218KB)Jayne Peterson
Advisors and Consultants
CDER, FDA
4:00pm – 4:30pmSkill Building for Reviewers in CDER (PDF - 456KB)CDR Rita Shapiro, M.A., D.P.T.
Office of Executive Programs
Division of Training & Development
CDER, FDA
4:30pm – 5:00pmCDER Public Transparency through WWW (PDF - 742KB)Monica Unger, M.L.S.
Web Project Manger
Division of Information Services
Office of Training and Communication 
CDER, FDA

 

Tuesday, April 21, 2009    
Review of New Molecular Entities

Moderator: Justina Molzon, M.S., Pharm, J.D.

Time

Topic

Presenter

9:00am – 10:15amDrug Review Process (PDF - 269KB)Ann Farrell, M.D.
Office of New Drugs
Division of Drug Oncology Products
CDER, FDA
10:15am – 10:30amBreak 
10:30am – 12:00pmRegulatory Drug Review (PDF - 17KB)
(panel)

Renmeet Grewal, Pharm. D. – Project Management/Moderator

Audrey Gassman, M.D. – Med. Officer

Angelica Dorantes, Ph.D.

Daphne Ty Lin, Ph.D. – Statistician

Amy L. Ellis, Ph.D. – Pharm. Tox.

Cindy Kortepeter, Pharm. D. – Safety

12:30pm – 1:00pmGroup Photo 
1:00pm – 2:00pmLunchOn Your Own
2:00pm – 2:45pmQuality Review (Chemistry) (PDF - 277KB)Norman R. Schmuff, Ph.D.
Branch Chief
Office of New Drug Quality Assessment
Office of Pharmaceutical Science
CDER, FDA
2:45pm - 3:30pmQuality Review (Biologics) (PDF - 1067KB)Patrick Swann, Ph.D.
Deputy Director
Division of Monoclonal Antibodies
Office of Biotechnology Products
CDER, FDA
3:30pm - 4:15pmSpecial Reviews (Pediatrics) (PDF - 686KB)Elizabeth Durmowicz, M.D.
Team Leader
Pediatric and Maternal Health
Office of New Drugs
CDER, FDA
4:15pm – 4:30pmBreak 
4:30pm – 5:30pmLabeling Overview (PDF - 330KB)Justina Molzon, M.S., Pharm, J.D.
Associate Director
International Programs
CDER, FDA

 

Wednesday, April 22, 2009    
Review of Over-the-Counter and Generic Drugs

 

Moderator: Justina Molzon, M.S., Pharm, J.D.
 

Time

Topic

Presenter

9:00am – 9:45amRegulation of Over-the-Counter (OTC)Drugs (PDF - 553KB)Leah Christl, Ph.D.
Associate Director for Regulatory Affairs
Office of Non-prescription Products
CDER, FDA
9:45am – 10:30amReview of the OTC Drugs Team - Compliance Issues (PDF - 368KB)Spencer Salis, Pharm. D.
Regulatory Operations Officer (OTC)
Division of New Drugs and Labeling Compliance
Office of Compliance
CDER FDA
10:30am - 10:45amBreak 
10:45am – 12:15pmOverview of the Generic Drug Process (PDF - 1486KB)Ted Sherwood
Management Analyst
Office of Pharmaceutical Science
CDER, FDA
12:15pm – 1:30pmLunchOn Your Own
1:30pm – 3:00pmANDA Review Process, CMC Perspective (PDF - 449KB)Suhas Patankar, Ph.D.
Division of Chemistry
Office of Generic Drugs
Office of Pharmaceutical Sciences
CDER, FDA
3:00pm - 3:15pmBreak 
3:15pm – 4:45pmBioequivalence Recommendations (PDF - 220KB)Leah N. Williamson, Ph.D.
Kuldeep R. Dhariwal, Ph.D.
Division of Bioequivalence
Office of Generic Drugs
CDER, FDA

 

Thursday, April 23, 2009    
Compliance

 

Moderator: Justina Molzon, M.S., Pharm, J.D.
 

Time

Topic

Presenter

9:00am – 9:30amCompliance Overview (PDF - 133KB)Jason Woo, M.D.
Associate Director of Scientific and Medical Affairs
Office of Compliance
CDER, FDA
9:30am – 11:00amDivision of Manufacturing and Product Quality (DMPQ), Office of Compliance 
 

Monica Caphart, M.S.

 Colleen Hoyt
 Yumi Hiramine
 Israel Santiago
 Douglas Campbell, B.S.
11:00am – 11:15amDMPQ: Questions and Answers 
11:15am - 11:30amBreak 
11:30am – 12:15pmRole of CDER in Bioresearch Monitoring Program (PDF - 272KB)Connie Lewin, M.D.
Medical Officer
Division of Scientific Investigations 
Office of Compliance 
CDER, FDA
12:15pm - 1:00pmBioequivalence and Good Laboratory Practice (PDF - 123KB)Jacqueline O'Shaughnessy, Ph.D.
Pharmacologist
Division of Scientific Investigations 
Office of Compliance 
CDER, FDA
1:00pm - 2:00pmLunchOn Your Own
2:00pm – 3:30pmPanel: Division of New Drugs and Labeling, Office of Compliance, CDER, FDA (PDF - 1080KB) 
 
  • Overview

Kathleen R. Anderson, Pharm. D.
Deputy Director

 
  • Internet and Health Fraud

Elizabeth Miller, Pharm. D.
Pharmacist - Acting Team Leader Internet and Health Fraud Team

 
  • New Drugs and Labeling

Karen Rothschild, Esq.
Regulatory Counsel
New Drugs and Labeling Team

 
  • Imports Exports
Huascar Batista, M.P.H
Team Leader, Imports Exports Team
 
  • Pharmacy Compounding

Sudha Shukla, Pharm. D.
Pharmacist, Compounding Team

3:30pm - 3:45pmBreak 
3:45pm – 5:00pmCompliance Risk Management and Surveillance (PDF - 365KB)

John Coburn and
Suzanne Barone, Ph.D.
Division of Compliance Risk Management and Surveillance

 

Friday, April 24, 2009    
Postmarketing

 

Moderator: Justina Molzon, M.S., Pharm, J.D.
 

Time

Topic

Presenter

9:00am – 10:00amOverview of Drug Safety (PDF - 282KB)Gerald Dal Pan, M.D. M.H.S.
Director
Office of Surveillance and Epidemiology
CDER, FDA
10:00am - 10:15amBreak 
10:15am – 11:15amOverview of Drug SafetyGerald Dal Pan, M.D. M.H.S.
Director
Office of Surveillance and Epidemiology
CDER, FDA
11:15am - 1:00pmLunch On Your Own
1:00pm – 1:45pmDrug Marketing, Advertising, and Communications (PDF - 1452KB)Barbara Chong, Pharm.D., BCPS
Team Leader
Division of Drug Marketing, Advertising, and Communications
Office of Medical Policy
CDER, FDA
1:45pm – 2:30pmMedical Errors (PDF - 3080KB)Denise Toyer, Pharm. D.
Division of Medication Errors Prevention and Analysis
Office of Surveillance and Epidemiology
CDER, FDA
2:30pm – 3:00pmFDA on WWW Wrap-upMonica Unger, M.L.S.
Web Project Manager
Division of Information Services
Office of Training and Communications
CDER, FDA
3:00pm – 3:30pmCertificate Presentation and Review of the Contents on the Flash Drive; Farewell 

 

 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, as well as the required security form :

  • Name
  • Position
  • Title
  • Country and Drug Regulatory Authority
  • Address
  • Phone
  • E-mail
  • Completed security form


 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