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• Managing Clinical Trials and Drug Approvals in China

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• Launching New Drug Products in Asian Markets: Strategies for Reducing Timelines and Costs

Pharma Regulatory Affairs Asia Presentations

• A New Paradigm for Pharmaceutical Regulation in Taiwan - TFDA Establishment
  Hsueh Yung Tai, Senior Specialist of Division of Drug and New Biotechnology Products, from the Food and Drug Administration, Department of Health, Executive Yuan, Taiwan, R.O.C. gives us an in-depth understanding of regulatory environment in Taiwan


• Biosimilars Regulatory Landscape & Challenges in Asia
  Wong Kum Cheun, Director Global Regulatory Affairs Strategic Policy and Support, Policy and Intelligence for Johnson and Johnson Pharmaceuticals Group help us understand the current regulations and guidelines for biosimilars in Asia. He also explains the biosimilars approval pathway in EU and US as well as the challenges for both regulators and industry to overcome.


• Current Topics in Regulation, Reimbursement & Pricing of Biologics
  Stephen F. Amato, Head of Regulatory Affairs Department for the Northeastern University, gives us his take on the evolving biotechnology market access landscape in the US.


• Optimising Pricing, Reimbursement and Healthcare System
  Jim Crompton, Manager of Reimbursement Strategies, for Medicines Australia gives us his take on optimising pricing, reimbursement and the healthcare system.

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