Regulatory Affairs for Clinical Development Interest Group
The goal of the RACD interest group is to expedite clinical development by providing accessible information on regulatory expectations during the development of clinical products. The RACD will serve as a forum for participants to exchange information on regulatory requirements and strategies. We provide fellowship and education to those interested in navigating the complex regulatory requirements for the development of investigational agents and devices. The interest group hopes to attract members of clinical development teams including those involved in the chemistry and manufacturing processes, nonclinical in vitro and in vivo studies (including IND directed pharmacology and toxicology studies), clinical studies, statistics, data management, regulatory affairs and human subjects research protection
NIH intramural and extramural scientists are invited to become members of the RACD interest group. The invitation to join the RACD is extended to staffs at the Food and Drug Administration and other Federal Government Agencies. Please join our listserv and also add your name to our member list.
RACD events are announced through the listserv and this website. The interest group moderators are Carrie Laurencot and Mary Ann Toomey (email@example.com).
Join the listserv by clicking on RACD-L.
The next meeting will be on April 10th from noon-1:00 PM for a presentation by Kelly Cahill, RN, MS, CCRC, RAC (US),Clinical Research Oversight Manager, Intramural Safety Office and DSMB, NIAID and Barry A. Eagel, MD, CPI,Clinical Safety Director,Regulatory Compliance and Human Subjects Protection Program/NIAID. The topic for discussion is "Compliance with FDA Safety Reporting Requirements: A NIAID Approach".
This presentation will be given in Bldg 10/CRC Rm. 2-3330 (2nd floor, in the east wing), with teleconferencing to Frederick (ATRF), Executive Plaza North (EPN) (or Shady Grove) and Industry Lane in Frederick. The call in #, will be sent at a later time.