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Overview of ICH [Pdf
[149 KB)]
Presented: October 21, 2008, to the public in Hilton Washington DC / Rockville Hotel
Presenter: Justina A. Molzon, M.S. Pharm., J.D., Associate Director for International Programs
Text version
Implementation of ICH Gls in Japan - Improving regulations through harmonization - [Pdf
[240 KB)]
Presented: October 21, 2008, to the public in Hilton Washington DC / Rockville Hotel
Presenter: Toshi Tominaga, FDA Fellow (MHLW)
Text version
Current and Future Role of ICH GCG [Pdf
[172 KB)]
Presented: October 21, 2008, to the public in Hilton Washington DC / Rockville Hotel
Presenter:
Mike Ward
, Health Canada
Text version
Overview and Update on ICH Genomic Biomarker Guidelines E15 and E16 [Pdf
[244 KB)]
Presented: October 21, 2008, to the public in Hilton Washington DC / Rockville Hotel
Presenter: Lois Hinman, E16 Rapportuer, PhRMA
Text version
ICH Public Meeting - E2F: The DSUR [Pdf
[80 KB)]
Presented: October 21, 2008, to the public in Hilton Washington DC / Rockville Hotel
Presenter: Vernon Stringer, M.D., M.Sc., Manager, AIDS and Viral Diseases Division
Therapeutic Products Directorate, Health Canada
Text version
ICH Topics on Quality [Pdf
[44 KB)]
Presented: October 21, 2008, to the public in Hilton Washington DC / Rockville Hotel
Presenter: Jon Clark, FDA/CDER/OPS
Text version
electronic Common Technical Document [Pdf
[60 KB)]
Presented: October 21, 2008, to the public in Hilton Washington DC / Rockville Hotel
Presenter: Louis Boulay, Director, Submission and Knowledge Management Division
Veterinary Drugs Directorate, Health Canada
Text version
ICH M2 Activities [Pdf
[52 KB)]
Presented: October 21, 2008, to the public in Hilton Washington DC / Rockville Hotel
Presenter: Mary Ann Slack, Director, Office of Business Process Support, CDER
Text version
Summary of ICH Safety Topics [Pdf
[153 KB)]
Presented: October 21, 2008, to the public in Hilton Washington DC / Rockville Hotel
Presenter: Abby Jacobs, FDA
Text version
Comments on the Draft Document: "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals" in response to Docket No. FDA-2008-N-0484 [HTML; Pdf [392 KB]]
Alcon Written Comments for Consideration by the Food and Drug Administration [HTML; Pdf [68 KB]]