Conference & Events
Event Details
Making All Data Count: FDA Acceptance of non-US Clinical Trials
This webinar will help you understand how non-IND clinical trials at non-US locations can be used successfully to support an IND/IDE or a marketing approval application. It will cover the critical product specific issues (drugs, biologics, diagnostic kits and medical devices) that need to be addressed when using non-US data for discussions with FDA.
Date: 07 June 2012 08:00 - 09:00
Event Subject(s):
Education
Venue
2600 E. Bayshore Road
Palo Alto
94303
United States of America
Find this location using Google Map
Useful link:
http://www.complianceonline.com/ecommerce/control/train...
Organiser Information
Organiser(s): ComplianceOnline
Contact for Event Information
Name : Referral
Address:
2600 E. Bayshore Road
Palo Alto
94303
United States of America
Tel:
1-650-620-3915
Fax:
1-650-963-2556
Email:
referral@complianceonline.com
Contact Useful link:
http://www.complianceonline.com/ecommerce/control/train...
Additional Information
Speaker Information:
Dr. Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA.
