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 (toomeym@mail.nih.gov).

Join the listserv by clicking on RACD-L. 

Please join us on December 12th from 2:00-3:00 PM for a presentation by Keith Wonnacott, Ph.D.,   Chief, Cell Therapies Branch, Division of Cellular and Gene Therapies , OCTGT, CBER, FDA.
Dr. Keith Wonnacott will be discussing ancillary products and new issues in cell therapy.  

This presentation will be given in Bldg 10/CRC Rm. 2-3750 (2nd floor, in the west wing), with teleconferencing to Frederick (ATRF) E1108 conference room, and Executive Plaza North (EPN)  8051 conference room.  Please let me know if you want to reserve a conference room in your building for this presentation. The call in # is 800-779-8303, pass code 54220. We have limited t-con lines, so please let me know if plan to call in.

Directions to Rm 2-3750:  From the Main Lobby of the CRC, go down the right corridor past the fish tank.  (Do not take the Central Elevators.)  Look for the "1 West Corridor" sign on your right and take that door to the end of the hallway.  Then take the "Southwest Elevators" up one flight to the second floor. Conference Room 2-3750 is located in the glass enclosure next to the elevator lobby.