Learning objectives

• Understand the key new requirements for approval of clinical trials; Global Development of Clinical Trials to support MAA/NDA from Chinese perspective; New Initiatives instigated by CFDA to speed up drug development for the Chinese market
• Understand how to form the new regulatory strategy according to the new regulatory changes in China

Target audience

This webinar is for regulatory professionals who deal with global market and form global regulatory strategies. It will also benefit the those from other functions who would like have some understanding of the China market.

Presenter

Dr Ziqun Han is specialised in regulatory policy and intelligence for global pharmaceutical/biotech markets, with a focus on EU and Asia Pacific regions.
She 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 developments. She has been also 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.  

CPD

This course offers 1 CPD hour for successful completion. To learn about why CPD is important visit the Lifelong Learning page.

How do I register?

Prices

Discounted Places

A limited number of discounted places are available at the rates below for those:

• in low income countries as defined by the World Bank
• working for agencies, charities or NGOs. 

Please email meetings@topra.org for a discount code before making your booking.

* VAT, if applicable, is charged at a rate of 20%.

Terms and conditions

Please read the training terms and conditions before purchasing this webinar. By purchasing this webinar, you are agreeing to the terms and conditions.