Overview of SG2 Information Session Brief

8th GHTF Conference - Ottawa, Canada

This brief is also available in Word and PDF format.

Title:	Overview of SG 2
Time:	Friday, 22 September 9:00 AM - 9:45 AM
Convenor:	Deb Blum United States Food and Drug Administration Tel: 301-594-2985 Fax: 301-594-1967 Email: dyb@cdrh.fda.gov
Topic:	Overview of SG2- Deb Blum Who we are: countries and organizations represented on SG2 What we are about: brief review of SG2 charge and mission statement Where we are going: what SG2 will present today, and some new projects we are developing
	The NCAR/Vigilance Report Exchange Program- Kim Dix Overview of the Program Training considerations Confidentiality issues
	SG2 N21 Manufacturer Reporting Guidance- Ben Khosravi What constitutes a reporting event, with examples The exemptions to the reporting rules, with examples
	Key Projects- Carl Wallroth Introduction to N32:Mfr. Universal Dataset; N 33:Mfr. Report Timeframes; N 36:Mfr. Trending of AEs; Use Error Reporting
Goals for this presentation:	Attendees will have increased knowledge and appreciation for the mission of SG2, key SG2 guidances and programs currently available, as well as ongoing SG2 projects.

Updated 22 July 2004