From: Wendypstephenson@aol.com
Sent: Wednesday, March 16, 2005 2:13 PM
To: stanisicn@cder.fda.gov; FDADockets@oc.fda.gov
Subject: Docket No. 2005N-0038 March 21 Hearing on IRBs
RE:  Docket No. 2005N-0038
 
Dear Ms. Stanisic,
 
Please find attached a letter, which includes a statement of the position of the CIOMS VI Working Group with respect to the Reporting of Adverse Events to Institutional Review Boards, and a copy of my slides.  I will be sending hard copy via FedEx.  Thank you for the opportunity to participate in the FDA Hearing on this subject on March 21, 2005.
 
Regards,
 
Wendy P. Stephenson, MD, MS, MPH
Wendy Stephenson & Associates LLC
Expertise in Pharmaceutical Safety
1816 Carmel Place
Maple Glen, PA 19002

Tel: 215-628-2755
Fax: 215-540-0232
e-mail: wendypstephenson@aol.com
Website: www.wendypstephenson.com