DUBLIN--(BUSINESS WIRE)--Feb 22, 2019--The "Pharmaceutical Regulatory Affairs in Asia" conference has been added to ResearchAndMarkets.com's offering.
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.
Gain an overview of the Asian MarketsDiscuss outlines of company and product registrationUnderstand the Application ProcessAssess the impact of recent regulatory developments in the regionDiscuss harmonisation initiatives including ASEAN opportunitiesUnderstand how Japan fits in the Asian regulatory landscapeDiscover general country specific and regional requirements
Why You Should Attend
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 AsiaDiscussion of underlying official regulatory sourcesAn interpretation of practical aspectsAn overview of the requirements for local manufacturingRecent developmentsHarmonisation initiativesAn update and wider knowledge of regulatory affairs in AsiaThe opportunity to exchange experiences with other delegates
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.
Agenda
Day I: China, Hong Kong SAR, Introduction to ASEAN, Brunei and the Philippines
Day II: India, Indonesia, Malaysia, Singapore and Thailand, Cambodia, Laos, Vietnam
Day III: Taiwan, Korea, Brief Comparison of Japan, ASEAN Harmonisation
The markets
Brief commercial and cultural backgroundImportance of major markets
Company and product registration
Regulations and guidelinesDrug classification systemsSite registrationNew productsLine extensionsLabelling changesSourcing changesRegistration samplesCertificates/legalisation
Application process
Committees/meetingsNew applicationsVariationsRenewals/re-registration
Recent regulatory developments
Influences and changes: national and regionalThe latest regulatory developments in the region
Harmonisation initiatives
ASEAN opportunitiesA brief comparison of how Japan fits into the Asian regulatory landscapeGeneral country-specific and regional discussions
CONTACT: ResearchAndMarkets.com
Laura Wood, Senior Press Manager
For E.S.T. Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics:Drug Discovery
KEYWORD: UNITED KINGDOM EUROPE
INDUSTRY KEYWORD: EDUCATION HEALTH PHARMACEUTICAL TRAINING
SOURCE: Research and Markets
Copyright Business Wire 2019.
PUB: 02/22/2019 10:39 AM/DISC: 02/22/2019 10:39 AM
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