Current Edition

International Pharma Regulatory Summit 27th-28th July 2017, Singapore

Effectively interpret complicated regulatory guidelines to fast track your drug approval process

Early Confirmed Speakers:
  • Dr Stephen Hsu, Associate Director Commercial Quality APAC,Teva
  • May Ng, Regulatory And Quality Consultant, Founder, ARQon Pte Ltd
  • Shibu Baburaj, Head, Regulatory Affairs/ CMC, Sanofi-Aventis
  • Dimas Adityo, Compliance Director/Head of Ethics & Business Integrity, Sanofi Indonesia
  • Dom LaVigne, Director of Government & Public Affairs – Asia Pacific/Middle East, Methanol Institute
  • Ranjodh Gill, Compilance Manager Quality Assurance, Parexel
  • Rakesh Chaurasia, Head Drug Regulatory Affairs, PT Dexa Medica
To request the Latest Agenda & more details on the Programme, Speakers and their Presentations by email, please click here>> 
Specialist Content: 
  • Regulatroy submissions implementation in eCTD format
  • The ASEAN Labelling Harmonisation Effort
  • Registration and approval timeline – combination products and exemptions
  • What’s new with clinical regulatory requirements in Asia Pacific?
  • Global trends vs. specific region’s updates for pharmacovigilance
  • Regulatory affairs support in providing advices to commercial team for inspection
  • Global Guidelines for the Development of Biologics
Why Attend?
Effectively interpret complicated regulatory guidelines to fast track your drug approval process
Asia’s regulatory systems are diverse, and oftentimes challenging to navigate. The regulatory agency in each Asian country has its own set of regulations and customary manner of conducting business. Thus, determining the most effective and efficient strategy to obtain approval for your pharmaceutical product from each regulatory body without sufficient knowledge and experience with Asian regulatory affairs can be a very difficult task.
Who Will Attend?
ACI’s seminars attract a targeted group of senior level executives with a strict focus on end-users from the industry.Directors/Heads/Managers of Regulatory Affairs, Quality Control, Quality Assurance, Patent/Intellectual Property Rights /Legal, Pharmacovigilance/Drug Safety 
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