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, Germany
Yuwei Heinzel is a regulatory expert for the registration of API/Excipient/Drug, covering all countries and regions worldwide. She has more than 17 years of regulatory experience in the pharmaceutical industry. She is now head of pharma registration, Germany, within the regulatory management of Merck. She is a member of the European APIC working group of emerging markets, M4Q(R2), and vice chair of the China Task Force. She is also a member of the German Regulatory Affairs Association (DGRA).
Cloris Tian
Merck
Senior Regulatory Manager, Greater China
Cloris has a background in biologics and has worked in various roles in R&D and customer service functions. Additionally, she is armed with decades of regulatory affairs working experience, covering pharmaceuticals, food, and chemical industries. Her expertise lies in the regulatory field of pharmaceutical excipients globally and in China. She was also on the founding board to establish IPEC (International Pharmaceutical Excipient Council) in China in 2008 and chaired it. Her associations with IPEC have continued for a decade.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
期间:1h
语言:English
场次 1:往期 August 15, 2023
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