FDA Regulated Research Conference

The Center for Clinical and Translational Science  in collaboration with The Ohio State University Office of Responsible Research Practices  and Nationwide Children’s Hospital  will host a FDA-focused conference entitled “FDA Regulated Research: FDA Review and Audit Preparedness.” The conference will include a number of speakers from academic institutions, regulatory experts, The Ohio State University, Wexner Medical Center, OSU College of Veterinary Medicine, and Nationwide Children’s Hospital, the FDA and will focus on the following key topics:

• The use of animal models for phase one drug development

• Biologics and the FDA submission process

• Risk Management

• Audit preparation

• Keynote speaker: David Burrow, Director, Office of Scientific Investigations, Center for Drug Evaluation and Research, FDA.
  
  Registration is limited.