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About The Conference

Increasing new and complex regulatory requirements adds more pressure to the demands and responsibilities to the regulatory affairs department.   Especially in Asia where the poorly defined and rapidly evolving regulatory landscape can cause timeline delays in getting approvals which will ultimately affect the overall revenue generated. Due to the differences in various regulations, a good grasp of local regulatory knowledge is the one of the key to success in any new market.

IBC’s Asia Pharmaceutical Regulatory Series is the longest running event of its kind in Asia and this is the 2nd time it is going to be held in China with an East Asian focus. The 2nd Pharmaceutical Regulatory Summit Asia ensures that you go home with a firm knowledge in the regulatory environment in Asia by hearing and learning from the experience of regional and international regulatory experts to ensure a profitable and success in accessing the Asian pharmaceutical markets

Reviews from our past 2013 event

’Good coverage of topics’’
Vifor Pharma Asia

‘’A well-organized conference event where there are experience sharing and knowledge gaining at the same time’’
InQpharm Group

‘’Very Informative!’’
Besins Healthcare

‘’Good to understand the Regulatory Affairs environment’’
Baxter

Key Topics to be Covered This Year Include:
  • Regulatory Updates from China & East Asia
  • Guidelines of Various Products including: Biosimilars, OTC, Orphan Drugs and Fixed-Dose Combination (FDC) Products
  • Strategies to Fast Track your Product into China & East Asia
  • Opportunities for Bridging Studies and Waivers
  • Drug-Device Combination Products Guidelines
  • Industry Best Practices in Dossier Submissions
  • Advice in Transitioning to Paperless e-CTD Submissions
  • Pediatric Investigational Plans (PIPs) for Asia
Why You Cannot Afford to Miss this Event
  • Opportunity to hear the latest updates from: list the countries here
  • Ideal networking opportunities with regulatory representatives and industry experts
  • Wide variety of topics including biosimilars, market access, CMC and clinical trials
  • Interactive sessions for you to influence and discuss pharmaceutical  regulatory topics
  • Sharing of regulatory and industry experience
  • The ONLY event that has a China and East Asia regulatory focus: For an in-depth understanding of the region

Companies Who Attended Our Past Events include

Abbott Laboratories
Actelion Pharmaceuticals Ltd
Allergan Australia
Amgen Development K K
Astellas Pharma Inc
Australian Nuclear Science & Technology Organisation
Austrian Agency For Health Food Safety (AGES)
Bayer Healthcare Co Ltd
Bayer Korea Ltd
Beaufour-Ipsen (Tianjin) Pharmaceutical Ltd
Boston Consulting (Shanghai) Co Ltd
Covance Clinical Development Services
GlaxoSmithKline Far East B V
Hang Zhou Tigermed Consulting Co Ltd
Hospira Australia Pty Ltd
INC (Beijing) Medical Technology Co Ltd
Institut Pasteur of Shanghai
LFB Biotechnologies
Lundbeck Malaysia

Millennium Pharmaceuticals Inc
National Institutes for Food and Drug
Control
Novozymes (China) Investment Co Ltd
Octapharma Pharmazeutika Produktionsges mbH
Pfizer China
Raquelian Consulting
Sanofi China
Shanghai Henlius Biotech Co Ltd
Takeda Pharmaceuticals Korea Co Ltd
Takeda (China) Holdings Co Ltd
Takeda Pharmaceuticals (China) Co Ltd
The Hong Kong Association of the Pharmaceutical Industry
TTY Biopharm Co Ltd
Venturepharm Laboratories Ltd
VPS-CRO Group


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