International Programs

FDA’s Regulatory Framework and Online Tutorials

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The U.S. Food and Drug Administration’s (FDA), Office of International Programs (OIP) will host its third educational forum on FDA’s regulatory framework and online tutorials.

This forum is intended for officials representing the embassies, consulates and trade missions supporting the international regulatory authorities and the international regulated industries in the United States. The presentations and material will be given in English

On this page:


1. Objectives

  • To describe FDA’s Regulatory Authority and Rule making  
  • To describe FDA’s regulatory framework  
  • To provide details on the pre-and post-market programs related to regulation of prescription and over the counter drugs, medical devices, biologics, foods and cosmetics, and veterinary medical products 
  • To navigate FDA’s webpage for online tutorials related to regulation of FDA regulated products. 
     

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2. Date, Time, and Forum Location


Date
: Friday, June 20, 2014

Time: 9:00 a.m. to 5:00 p.m. EST

Location: White Oak Campus, 10903 New Hampshire Avenue, Building 31, The Great Room 1530 A, Silver Spring, Maryland 20993.

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3. Program and Speaker Biographies

Pdf Icon Printer Friendly Program [PDF 46KB]

TimeSubjectSpeaker
9:00 a.m.Opening RemarksSema Hashemi, M.S. (Speaker Bio)
Acting Deputy Director, Asia-Pacific Office, OIP, OC
9:05 a.m.FDA’s Regulatory Framework - An Overview
- FDA in US Government
- FDA’s Regulatory Authority and Rule making
- FDA Centers and Regulated Products
Presentation [175 KB]
Lawrence Bachorik, Ph.D. (Speaker Bio)
Assistant Commissioner for Communications, Office of External Affairs, OC
9:30 a.m.Q & A 
9:45 a.m.Center for Drug Evaluation and Research
- Overview of Pre and Post-Market programs in Prescription and Over The Counter Drugs
Presentation [221 KB]
Beth Duvall (Speaker Bio)
Associate Director for Regulatory Affairs, Office of New Drugs, CDER
10:30 a.m.Q & A 
10:45 a.m.Break 
11:00 a.m.Center for Biologics Evaluation and Research
- Overview of the Regulatory Approaches to Biological Products
Presentation [134 KB]
Peter Marks, M.D., Ph.D. (Speaker Bio)
Deputy Director, CBER
11:45 a.m.Q & A 
12:00 noonLunch on your Own 
1:00 p.m.Center for Devices and Radiological Health
- Overview of Pre- and Post-Market programs in Medical Devices
Presentation [348 KB]
Sousan S. Altaie, Ph.D. (Speaker Bio)
Senior International Policy Analyst, Asia-Pacific Office, OIP, OC
1:45 p.m.Q & A 
2:00 p.m.Center for Food Safety and Applied Nutrition
- Overview of Pre- and Post-Market programs in Foods and Cosmetics
Presentation [1.7 MB]
Jeffrey Read, M.S.F.S. (Speaker Bio)
International Policy Analyst, International Affairs Staff, CFSAN
2:45 p.m.Q & A 
3:00 p.m.Break 
3:15 p.m.Center for Veterinary Medicine
- Overview of Pre- and Post-Market programs in Veterinary Medical Products and Feed
Presentation [823 KB]
Merton V. Smith, Ph.D., J.D. (Speaker Bio)
Director, International Programs and Product Standards, CVM
3:45 p.m.Q & A 
4:00 p.m.FDA’s Regulatory Tutorials Online and Webpage NavigationPresentation [447 KB]
Christopher Jacquette (Speaker Bio)
International Policy Analyst, Asia-Pacific Office, OIP, OC
4:45 p.m.Closing RemarksSema Hashemi, M.S. (Speaker Bio)
Acting Deputy Director, Asia-Pacific Office, OIP, OC

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5. Contact Us

For additional information, you may also contact Dr. Sousan Altaie at Sousan.Altaie@fda.hhs.gov.

 

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Page Last Updated: 07/14/2014
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