Preparation for ICH Steering Committee and Expert Working Group Meetings in Fukuoka, Japan; Regional Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled “Preparation for ICH Steering Committee and Expert Working Group Meetings in Fukuoka, Japan” to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Fukuoka, Japan. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Group meetings in Fukuoka, Japan, November 6-11, 2010, at which discussion of the topics underway and the future of ICH will continue.
Date and Time: The meeting will be held on Wednesday, October 13, 2010 from 2:30- 4:30 pm.
Location: The meeting will be held at the Washington Theater at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750 Rockville Pike, Rockville, Maryland 20852.
Contact Person: All participants must register with Ms. Jennifer Haggerty, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, by email: firstname.lastname@example.org or fax: 301-595-7937.
Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentation, to the contact person by 5 p.m. e.s.t. on October 11, 2010.
If you need special accommodations due to a disability, please contact Jennifer Haggerty at least seven days in advance.
ICH Overview, Dr. Michelle Limoli(PDF - 84KB) [ARCHIVED] Overview on Quality, Jon Clark, FDA(PDF - 119KB) [ARCHIVED] Overview of Safety, Abby Jacobs, FDA(PDF - 56KB) [ARCHIVED] Update on eCTD, Joe Cipollina, Pfizer(PDF - 94KB) [ARCHIVED] Overview of the GCG, Mike Ward, Global Cooperation Group(PDF - 125KB) [ARCHIVED]