PHARMACEUTICAL
REGULATORY AFFAIRS
IN LATIN AMERICA

Conference Date: 17-19 Nov 2008
Conference Ref: A11-6008
Fee: £1590 + VAT
Venue: The Rembrandt Hotel, London

This seminar will provide up-to-date coverage of the requirements that underpin a successful marketing authorisation application for pharmaceutical products across Latin America.  In a carefully structured programme, speakers will cover the official regulatory sources but will also share their interpretation and alternatives to local/specific legal requirements that only people with hands-on experience in the region can provide.

This seminar will also include an overview of the regulatory aspects of site inspection for Brazil, Mexico and Colombia and the requirements for the marketing of NCE Biological Products, Generic drugs and OTC medicines.    Interactive workshops have been incorporated into the programme where participants will be invited to put learning into practice through the resolution of case studies.

It is anticipated that the seminar will be useful both as an introductory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject areas.