Excipient Regulations for Drug Product Registration in China
WEBINAR
In China, the registration, co-review process, and the use of ChP (Chinese Pharmacopoeia) compliant excipients can appear complex and time-consuming. With years of experience and regulatory expertise in China, we will provide an update on implementation of the excipient co-review procedure and reflect on the importance of the same during drug approval process. We will expand upon the process of ChP advocacy and share learnings from challenges we have encountered.
Finally, we will take a deep dive into regulatory trends for excipients in China, including ICH (International Council for Harmonisation) guidance status and microbial requirements for excipient use in sterile and non-sterile drug products.
In this webinar, you will learn:
- How to navigate the registration and co-review process of excipients in China
- How to deal with excipient-related challenges during drug approval process in China
- The significance of ChP advocacy
Speakers
Yuwei Heinzel
Merck
Head of Pharma Registration
Yuwei holds a Master’s degree in Chemistry and Drug Regulatory Affairs and has nearly two decades of experience in the global registration of APIs, excipients, and drug products. She possesses deep regulatory expertise in GMP requirements for pharmaceutical raw materials and worldwide product registrations. She is an active member of the European APIC Working Group on Emerging Markets, M4Q(R2), the China Task Force, and the German Regulatory Affairs Association (DGRA).
Cloris Tian
Merck
Senior Regulatory Expert
Cloris is a Senior Regulatory Expert, China. She holds a Master’s degree in Biological Sciences and has over 20 years of experience in biologics R&D, product registration, and regulatory affairs across pharmaceuticals, excipients, food additives, chemicals, and life sciences. Cloris specializes in monitoring global regulations, strategic analysis, and regulatory training. She has served multiple terms on the IPEC Federation board and currently chairs IPEC China.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
期间:1h
语言:English
场次 1:往期 August 15, 2023