The workshop was designed jointly with the Pharmacopoeia of the People’s Republic of China to enable participants to expand their knowledge and familiarise themselves with the regulatory framework in the field of pharmaceutical excipient, a rapidly evolving field in China.
Watch this webinar to learn about the Pharmacopoeia of the People’s Republic of China (ChP) and developments in 2018.
The programme covers topics such as:
- The implementation of various examination and approval systems
- How standards for pharmaceutical excipients in the ChP are established
- Risk management, technical requirements and the applicability of excipients
- The requirements to be met for the declaration of technical materials
- The quality control of excipients produced by different sources such as animals and plants.
This high-level event included the participation of top officials including Wei Zhang, Secretary General, Chinese Pharmacopoeia Commission and Susanne Keitel, Director, EDQM, Council of Europe.
Duration: 8 hours.
Target audience
This workshop is of interest to national regulatory bodies and professionals working in pharmaceutical companies in quality control, development, manufacturing, and regulatory affairs in the field of pharmaceutical excipients.
Download the presentations
- Chinese Pharmacopoeia (ChP) and Progress in the Compilation of ChP 2020, by Mr Zhang Wei
- Guidance on Pharmaceutical Excipient Suitability Studies (PESS) with Chinese Pharmacopoeia (Volume 4): Basics and Examples, by Dr Jiasheng Tu
- Establishment and Progress of the Standard System of pharmaceutical excipients in Chinese Pharmacopoeia, by Dr Xiaoxu Hong
- Risks, Classifying Management and Technical Requirements for Pharmaceutical Excipients, by Dr Xiaoxu Hong
- Submission Requirements for the Registration Application Dossier of Pharmaceutical Excipients, by Dr Jiasheng Tu
- Regulation of Pharmaceutical Excipients in China, by Dr Jiasheng Tu
- Considerations for Production and Quality Control of Animal Derived Pharmaceutical Excipients, by Dr Xiaoxu Hong
- Pharmacopoeial Convergence and Harmonisation, by Dr Susanne Keitel
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