Office of Regulatory Affairs and Quality IND Workshop (November 19, 2019)
The aim of this workshop is to educate clinical researchers on the regulatory requirements for clinical studies of investigational drugs that require an Investigational New Drug (IND) application, and to help the audience understand when those regulations apply. The workshop will cover FDA meetings, IND content, IND submission and review, IND maintenance, and the use of expanded access INDs. The goal of this workshop is to support a better understanding of FDA regulations that will lead to better compliance with those regulations.
Clinical research professionals, including physician investigators, regulatory professionals, study coordinators, and research nurses.
Provide an overview of the IND regulations that apply to clinical drug trials.
- 2.75 AMA PRA Category 1 Credit(s)™
- 2.75 ANCC
- 2.75 Attendance