Leveraging China Clinical Data for Global Development

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.

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