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.
Two weeks before the course starts, delegates will be enrolled on to the online element of the Pharmaceutical Regulatory Affairs in China course. Through this they will have access to:
Delegates will continue to have access to the online element, after the course has finished, for networking and development purposes.
This course is applicable to anyone interested in accessing the Chinese pharmaceutical marketplace.
Relevant job titles may include:
Relevant departments may include:
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.