This interactive workshop is designed for research, medical, and biotech professionals who need a practical understanding of the Investigational New Drug (IND) process. Topics include preparing for and conducting a pre-IND meeting, IND format and content, and leveraging FDA’s expedited pathways. The workshop will also address unique considerations for startups with limited resources, including selecting CROs and clinical investigators, filing submissions, and avoiding common pitfalls. Additional focus will be given to regulatory “watch outs” such as pre-approval promotion and presenting your program at scientific conferences.
