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

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

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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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Current Edition

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

Journal for Clinical Studies