International Council for Harmonization Regional Public Consultation, April 24, 2017
The FDA will be co-hosting a regional public consultation with Health Canada on April 24, 2017 to solicit public input prior to the next meeting of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) on May 28 – Jun 1. The ICH's mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. Experts from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research attend ICH meetings twice per a year, before each meeting the FDA conducts a public consultation to allow the public to comment on the topic areas. The topic areas relate to harmonization of various guidelines for the manufacture of pharmaceuticals.
Date:
April 24, 2017
Time:
11:00am – 2:00pm
Location:
10903 New Hampshire Ave.
Building 31 Rm 1503A
Silver Spring, MD 20993
Registration:
To register to attend this event, either in person or via the web, visit the event registration page:
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Meeting Agenda (PDF - 227 KB)
Webcast
Presentation Slides (PDF - 2.53 MB)
Information:
For more information on traveling to the White Oak campus: visit Public Meetings at the FDA White Oak Campus
Submitting Comments to the Docket:
In addition to providing input at the public meeting, the public is invited to provide comments through the public docket. The docket will close on May 12, 2017.
For questions regarding the meeting please contact:
Amanda Roache
Office of Strategic Programs
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
301-796-4548
Email: Amanda.Roache@fda.hhs.gov