This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan
BENEFITS OF ATTENDING
This seminar wil provide an overview of the key areas of pharmaceutical regulatory affairs in Asia, including India.
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 refresher course.
Personnel from Analytical Research and Development, Clinical Development, Quality Assurance, new business development departments, regulatory authorities.
DAY ONE
09.00 Registration and coffee
09.30 Meeting start
17.00 Meeting end
DAY TWO
09.00 Meeting start
17.00 Meeting end
DAY THREE
09.00 Meeting start
16.30 Meeting end
Day 1: China, Hong Kong SAR, Introduction to ASEAN, Brunei and the Philippines
Day 2: India, Indonesia, Malaysia, Singapore and Thailand, Cambodia, Laos, Vietnam
Day 3: Taiwan, Korea, brief comparison of Japan, ASEAN harmonisation
The Markets
Company and Product Registration
Application Process
Recent Regulatory Developments
Harmonisation Initiatives
A Brief comparison of how Japan fits into the Asian regulatory landscape
General Country-Specific and Regional Discussions
We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.
