Leveraging China Clinical Data for Global Development

China’s biopharma sector continues to generate innovative clinical assets with strong global potential. However, promising local data alone may not be enough to secure regulatory acceptance, market access and sustainable value in international markets.

In this on-demand webinar, experts from Ergomed Group and PrimeVigilance examine how companies can assess whether a China-led clinical development programme is ready for global expansion. The session explores the evidence regulators expect, the role of an internationally scalable pharmacovigilance system, and the early decisions that can influence approval, reimbursement and long-term asset value.

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Led by an accomplished professional in computerized systems quality, this webinar equips stakeholders in the healthcare and life sciences industries with the tools needed to align with emerging AI regulations while fostering innovation and ensuring compliance. Gain a deeper understanding of how to implement strategies that address data privacy, risk management, and evolving regulatory expectations.

What you will learn:

How FDA and EMA expectations can affect the use of China-led clinical data in global submissions
Which evidence gaps may require additional bridging data or a broader global development strategy
Why comparator selection, endpoints, population relevance and safety data can influence both regulatory and HTA outcomes
How to build pharmacovigilance capabilities that can support international clinical development and future commercialization
How to assess whether an asset is ready to proceed, requires targeted bridging evidence, or needs a redesigned global evidence plan