International Conference of Harmonization Regional Public Meeting, May 5, 2010
The Food and Drug Administration (FDA) is announcing a public meeting entitled “Preparation for ICH Steering Committee and Expert Working Group Meetings in Tallinn, Estonia” to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Tallinn, Estonia. 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 Groups meetings in Tallinn, Estonia, June 5-10, 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, May 5, 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, 5600 Fishers Lane, Rockville, MD 20857, by email: firstname.lastname@example.org or fax: 301-827-0003
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 April 30, 2010.
If you need special accommodations due to a disability, please contact Jennifer Haggerty at least seven days in advance.
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Justina A. Molzon, MS Pharma, JD, FDA/CDER/OEP
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Jon Clark, FDA/CDER/OPS
ICH Regional Public Meeting Update on Safety Topics(PDF - 69KB) [ARCHIVED]
David Jacobson-Kram, FDA/CDER/OND
Overview and Update on Electronic Standards Topics(PDF - 127KB) [ARCHIVED]
Gary M. Gensinger, MBA, FDA/OPI/OBI