CRES Event: Best Practices for Managing an Investigator-Sponsored IND

10 Dec CRES Event: Best Practices for Managing an Investigator-Sponsored IND

New to investigator-sponsored Investigator New Drug Applications (INDs)? Wonder how other research staff help their investigators manage INDs?

In this quarter’s CRES event, Jennifer Davies, Regulatory Affairs Associate at Fred Hutchinson Cancer Research Center, and Lacey Hedin, Quality Program Manager at Fred Hutch, will present principles and practices for supporting investigator-sponsored IND studies.

By attending this event, you will:

• Learn the difference between FDA regulations for sponsors vs. investigators
• Hear about the three most common academic scenarios for investigator-sponsored INDs
• Work in small groups to identify procedures and documentation requirements to ensure that sponsor-investigators meet their regulatory obligations for these three scenarios

This event is applicable to intermediate-level Regulatory Coordinators and Research Coordinators who work in an academic health sciences research environment. No prior working knowledge of investigator-sponsored INDs is required.

Join the live meeting via the CRES Adobe Connect site.

LOCATION

Fred Hutch
Thomas Building D1-084 (Sze East Conference Room)
1100 Fairview Ave. N.
Seattle, WA 98109

*Shuttles run from UW Health Sciences/UWMC to Fred Hutch, and from Harborview/Seattle Children’s Research Institute to South Lake Union (then take the UWMC/SLU shuttle to Fred Hutch). Learn More >