Michael Eric Oehlsen, Ph.D.
International Programs Team (IPT)
Center for Veterinary Medicine (CVM)
Dr. Michael Oehlsen became a member of CVM’s IPT 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.
His primary responsibilities as a member of the IPT include:
- Serving as the lead for CVM’s Bilateral, Trilateral, and Quadrilateral functions involving CVM’s international counterparts
- Acting as CVM’s Lead Representative on the FDA PIC/S Steering Committee
- Serving as IPT’s lead for FDA Tract and Key Activity Program Management
- Developing of IPT’s Quality System, Activity Reporting Database, Intranet and Internet Web Page, Information Database, International e-Communications Platform, as well as all other IT related projects
- Serving as CVM’s Lead for a Bilateral Cooperation with the European Medicines Agency for the Collaboration of cGMP Inspections of International Animal Drug Manufacturing Facilities
- Establishing and maintaining CVM’s International Travel Database for tracking proposed and pending international travel
- Serving as IPT’s liaison to CVM’s Employees International Volunteer Program.
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 polynuclear 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 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.