Effectively interpret complicated regulatory guidelines
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.
Against this backdrop, ACI brings you International Pharma Regulatory Summit 2017 will enable you to make confident, actionable decisions.
Highlighted features at 2-day conference includes
- Regulatory 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
Early Confirmed Speakers:
- Widyaretna Buenastuti, Public Affairs & Communications Director, Pfizer Indonesia
- May Ng, Regulatory And Quality Consultant,Founder, ARQon Pte Ltd
- Shibu Baburaj, Head, Regulatory Affairs, Sanofi-Aventi
- Dimas Adityo, Compliance Director/Head of Ethics & Business Integrity, Sanofi Indonesia
- Ranjodh Gill, Compilance Manager Quality Assurance, Parexel
- Rakesh Chaurasia, Head Drug Regulatory Affairs, PT Dexa Medica
Who Will Attend?
Directors/Heads/Managers of Regulatory Affairs, Quality Control, Quality Assurance, Patent/Intellectual Property Rights /Legal, Pharmacovigilance/Drug Safety
Previous Pharma Edition Attendees Included:
Abbott Manufacturing Singapore, Amcor, Apex Pharma Marketing Pte Ltd, ARQon Pte Ltd, Astellas Pharma Singapore Pte. Ltd,Avery Dennison Singapore (Pte) Ltd, Beacons Pharmaceuticals Pte Ltd, Constantia Flexibles International GmbH, Dätwyler Sealing Solutions, DKSH Singapore Pte Ltd, Dnahc Cambodia, Dr Reddy’s Laboratories, Ekberg Emballage AB, Esko Graphics, European Chamber of Commerce (Singapore), General Mills, GlaxoSmithKline Consumer Healthcare, Goldplus Universal Pte Ltd,HGP Asia Pte, ICM Pharma Pte. Ltd., Agency for Science Technology and Research (A*STAR), Klöckner Pentaplast, LF Asia Distribution, Medicell Pharmaceutical (S) Pte. Ltd, Mundipharma, MVK Meditech, National Environment Agency, Nicosia Creative Espresso Pte Ltd, Opto-Pharm Pte Ltd, Orient Design, Parexel International Pvt Ltd, Pharma Pharmaceutical Industries, PT Bayer Indonesia, PT Graha Farma, PT Kalbe Farma, PT Kino Indonesia, PT. Galenium Pharmasia Laboratories, RVK Meditech, Sanofi, SICPA, SPA Governing Board, Sun Pharma, Tesa Scribos GmbH, Teva Pharmaceutical, ThePackHub, Uhlmann Singapore LLP,UPM Raflatac, Versalis Spa, BOBST, Softbox Systems, SHL Group and many more…
If you would like to register, please let me know as soon as possible, so that I can secure your space with the discount.
For Agenda, Information & Registration: