Office of Responsible Research Practices
The Ohio State University

ORRP News

Therapeutic Development in Academia and the Challenges of FDA-regulated Research

Posted: March 2, 2018

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering a workshop on FDA considerations in drug and device research.  The workshop will:

  • Summarize the regulations governing development of investigational drugs and medical devices
  • Define FDA’s role in reviewing drug and medical device clinical trials
  • Explain what to expect during FDA inspections of clinical trials
  • Identify key resources for academic researchers embarking on their therapeutic development odyssey

The workshop will be held on Tuesday, March 20 from 8 to 9:30 a.m. in the Clinical Skills Education and Assessment Center, Room 620, 6th Floor Prior Health Sciences Library, 376 West Tenth Avenue.

Registration requested.

Contact: 614-688-8641 or meadows.8@osu.edu

Category : IRB / ORRP / Training