Pharmaceutical Regulatory Affairs in Asia

Course Overview

PLEASE NOTE: THE VENUE FOR THE APRIL 2019 OUTING HAS NOW CHANGED TO THE HOLIDAY INN FORUM

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia, including India, and will cover:

• All important aspects of gaining and maintaining a successful marketing authorisation in Asia
• Discussion of underlying official regulatory sources
• An interpretation of practical aspects
• An overview of the requirements for local manufacturing
• Recent developments
• Harmonisation initiatives
• An update and wider knowledge of regulatory affairs in Asia
• The opportunity to exchange experiences with other delegates

Benefits of attending:

• Gain an overview of the Asian markets
• Discuss outlines of company and product registration
• Understand the application process
• Assess the impact of recent regulatory developments in the region
• Discuss harmonisation initiatives including Asean opportunities
• Understand how Japan fits in the Asian regulatory landscape n Discover general, country-specific and regional requirements

Who should attend

This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and in-market regulatory compliance. You will find this seminar useful both as an introductory and/or a refresher course. Previous delegates have included:

• Scientists and technical staff in

- Regulatory affairs
- Registration departments

• Medical directors