Federal Register Notice (PDF - 150KB) by HC11281020032823


									                    ICH REGIONAL PUBLIC MEETING
                                     Hosted by:
                       U.S. Food and Drug Administration &
                Pharmaceutical Research and Manufacturers of America

                          Wednesday, May 5, 2010, 2:30 – 4:30 p.m.

              Hilton Washington DC / Rockville Hotel & Executive Meeting Center 

                Washington Theater, 1750 Rockville Pike, Rockville, MD 20852 

• Welcome
     Dr. Michelle Limoli, FDA

• The ICH Process in Review
     Dr. Justina Molzon, FDA

• Overview and Update on Quality Topics
    Dr. Jon Clark, FDA

• Overview and Update on Safety Topics
    Dr. David Jacobson- Kram, FDA

• Overview and Update on Electronic Standards Topics
    Mr. Gary Gensinger, FDA

• Update on eCTD
   Dr. Louis Boulay, Health Canada

• Overview and Update on Gene Therapy (M6)
   Dr. Beth Hutchins, PhRMA

• MedDRA
   Ms. Heather Sutcliffe, Health Canada

• Overview of the Global Cooperation Group
   Mr. Mike Ward, Health Canada

• Q&A

• Public Presentations

• Adjourn

To top