How to Communicate with Regulators During New Drug R&D?
A practical discussion on regulatory communication strategies throughout the drug development lifecycle, helping programs reduce detours, manage risk and improve execution efficiency.
Events & Insights
Events & Insights
We share practical insights on drug R&D, regulatory filing and clinical development strategy, making complex regulatory and development questions clearer.
Recent Events
Recent activities
Drug Registration and Clinical Development Strategy Seminar · Shanghai
Focused on China-US regulatory communication, review of overseas clinical data and dual filing strategies, with thematic sharing and one-on-one expert consultation.
Previous Workshops
Previous workshop topics
China-US expedited regulatory pathways and case studies
An overview of accelerated regulatory pathways in China and the US, with practical case-based development strategies.
How does FDA review clinical data from China?
A discussion of FDA expectations for foreign clinical data, data quality and compliance requirements.
What non-clinical studies are needed for cell and gene therapy?
Key considerations for pharmacology, pharmacokinetics and safety evaluation of CGT products.