PHARMACEUTICAL
REGULATORY AFFAIRS
IN CHINA

Conference Date: 11-12 Nov 2009
Conference Ref: A11-6209
Fee: £1240 + VAT
Venue: The Rembrandt Hotel, London

INTRODUCTION

This seminar will provide an up-to-date coverage of all aspects playing an important role in gaining and maintaining a successful marketing authorisation for R&D based pharmaceutical products in PR China. In this carefully balanced programme, speakers will cover the underlying official regulatory sources and share the interpretation and practical aspects of putting these into practice in a day-to-day scenario.

This seminar will also include an overview of the requirements for local manufacturing as well as of the patent situation and the current legal framework for pharmaceutical patents in PR China. 

An interactive session has been incorporated into the programme where participants will be invited to put learning into practice through the resolution of a case study. It is  anticipated that this 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 area.

WHO SHOULD ATTEND

The seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and in-market regulatory compliance including:

Scientists and Technical Staff in:
• Regulatory Affairs/RegistrationDepartments
• Medical Directors

Personnel from the following areas:
• Analytical Research and Development
• Clinical Development
• Quality Assurance
• New Business Development Departments
• Regulatory Authorities

SPEAKERS

Carl P Denny - Associate Director, Global Pharmaceutical Regulatory Affairs, Pacific, Asia and Africa Region at Abbott, USA
Pharmaceutical Regulatory Consultant, Switzerland - Speaker to be announced

TOPICS TO BE COVERED:

• Drug Market
• Drug Regulatory System
• Application Process
• Recent Regulatory Developments
• Clinical Development
• A way to expedite Regulatory Approval of an Import Drug
• Other Regulatory Aspects
• Putting Learning into Practice
• General Country Specific Discussion

Also on Day One: 11 November 2009 – 17.00-18.00 - Drinks Reception in the Hotel for Delegates and Speakers

IN-HOUSE TRAINING 
 
If you would like to discuss running this or any of our existing courses on an in-house basis, please contact: ellen.walker@management-forum.co.uk

Click here to book your place on this important annual event.