About FDA

Michael Eric Oehlsen, Ph.D.

Michael Eric Oehlsen, Ph.D.

Director, International Policy and Logistics
CVM International Affairs (CVM-IA)
Food & Drug Administration
Michael.Oehlsen@FDA.HHS.Gov

Dr. Michael Oehlsen became a member of CVM-IA in June 2010. His unique skill set includes an extensive background in drug design and development, scientific review of drug applications for regulatory decision-making, as well as FDA investigative policy and procedures regarding current Good Manufacturing Procedures (cGMP) for the pharmaceutical industry.

 Primary responsibilities as Director of International Policy and Logistics include:

  • Policy
    • FD&C, FDASIA
    • FSMA
    • OFVM International Liaison
    • CARB International
    • Confidentiality Commitments
    • Memoranda of Understanding
    • Systems Recognition and Mutual Reliance
    • Sanitary and phytosanitary measures and agreements
    • Non-Public Information Exchange
  • Logistics
    • International Affairs Operations
    • Intra- & Interagency International Activities Coordinator
    • Foreign National Visitors Security Clearance/Monitoring
    • Policy related activity tracking
    • FDA Track and Key Activity Program & Budget Management
    • CVM-IA Coordinator, International Volunteer Program
    • CVM-IA Quality System, Reporting Database Module, Information Systems,
  • Bi- and Multi-Lateral International Engagements
  • International Trade

Prior to employment with the FDA, he attended Virginia Commonwealth University - Medical College of Virginia where he obtained a Doctorate in Bioinorganic Chemistry. His focus of study was the development and synthesis of anticancer poly-nuclear platinum complexes. Dr. Oehlsen brought his knowledge of biochemistry and drug design to the FDA as a Regulatory Review Chemist in the Division of Manufacturing Technologies in June 2003. Since that time, he has expanded his drug review career to include the completion of FDA’s Investigator Agency Certification. He has participated in a cGMP investigation as a key Chemistry, Manufacturing, and Controls expert involving FDA’s Office of Criminal Investigations. Dr. Oehlsen later became a Certifying Instructor of Drug Application Science and Review for Level III FDA Investigator Candidates and has served on several FDA intra- and inter-agency working groups and task forces. Some of his experience in inter-agency work has involved regulatory requirements and policy related to key international interests of FDA.

Dr. Oehlsen resides in the Eastern Panhandle of West Virginia with his wife and son.
 

Page Last Updated: 04/03/2017
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