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Pharmaceutical Regulatory Affairs in China

2 - 3 October 2019

Radisson Blu Edwardian Kenilworth, London

Develop or market your drug in China more effectively with a deep understanding of the Chinese pharmaceutical regulatory landscape. In 2015 China’s pharmaceutical sector underwent significant regulatory reforms to align with EMA & FDA requirements, making the Chinese market one of the biggest pharmaceutical markets in the world. The reforms included clinical trial approval time being cut from 2 years to 60 days and the NMPA becoming a member of ICH.

During this course, you will learn fundamental Chinese regulatory requirements for pharmaceuticals and how they relate to the country’s economic and cultural background. Guided by our expert course leader you will discover best practices for registering new drugs and discuss the likely impact of the US – China Trade War on market access and drug development.

  • Understand how China’s cultural and economic background has impacted pharmaceutical regulations
  • Learn about reforms to legislation in China and the reasons behind the changes, including the development of the NMPA and the move to the 60-day clinical trial approval time
  • Learn best practices for successfully registering pharmaceutical products in China and the challenges which coincide with it
  • Familiarise yourself with the regulations governing biopharmaceuticals in China, evaluate the trends and gain an overview of CMC guidance
  • Understand the potential impact of the US-China Trade War on the Chinese pharmaceutical market

This course is applicable to anyone interested in accessing the Chinese pharmaceutical marketplace.

Relevant job titles may include: 

  • Heads of Department
  • Directors
  • Managers
  • Consultants

Relevant departments may include:

  • Project Management
  • Regulatory Affairs

Dr Ziqun Han

Dr Ziqun Han specialises in regulatory policy and intelligence for global pharmaceutical/biotech markets, with a focus on EU and Asia Pacific regions.

Dr Han has over 20 years of pharmaceutical/biotech drug development experience across a broad spectrum of therapeutic areas that include: Gene Therapy, Oncology, Neurology, immunology and Virology. In the past 10 years, Dr Han focused on helping leading global pharmaceutical/biotech companies understand global regulatory developments, and efficiently utilised those changes to shape regulatory strategies and product development. She has also been actively engaged with numerous trade associations and proactively advocates regulatory reforms to key regulators.

Dr Han’s educational credentials include a Bachelor of Medicine degree from the Capital University of Medical Science in Beijing, a PhD in Molecular Endocrinology from Imperial College, London and an Executive MBA from Imperial College, London.

 

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