2019 Annual CCTS FDA Conference

The CCTS  in collaboration with The Ohio State University Office of Responsible Research Practices  and Nationwide Children’s Hospital  hosted our annual FDA-focused conference entitled “FDA Regulated Research: FDA Review and Audit Preparedness” on June 11, 2019.

The conference welcomed more than 200 attendees from numerous institutes throughout the United States.

Presenters included a number of speakers from academic institutions, regulatory experts, and the FDA, and focused on topics like the use of animal models for phase one drug development, biologics and the FDA submission process, risk management, and audit preparation.

Keynote speaker, David Burrow, Director, Office of Scientific Investigations, Center for Drug Evaluation and Research, FDA, discussed his experience with the FDA including working through the auditing process and best practices when communicating with the FDA.