Venue: EDQM Premises, 7 allée Kastner, 67081 Strasbourg, France
Working language: English
The workshop has been designed jointly with the Pharmacopoeia of the People’s Republic of China to enable participants to expand their knowledge and familiarise themselves with the current regulatory framework in the field of pharmaceutical excipient, a rapidly evolving field in China.
Participants will learn about the Chinese regulatory system and the Pharmacopoeia of the People’s Republic of China (ChP), the role and mission of the China Food and Drug Administration (CFDA) and the latest developments of the ChP.
The programme will cover 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 will include the participation of top officials including Wei Zhang, Secretary General, Chinese Pharmacopoeia Commission and Susanne Keitel, Director, EDQM, Council of Europe.
During the workshop, there will be ample time for interacting with the speakers and for networking.
Draft programme available HERE.
Who should attend?
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.
It will also attract many Chinese and international excipient and finished-drug manufacturers.
NEW! Register for free for the Live Broadcast
If you cannot make it to Strasbourg, you can register for the Live Broadcast to view this workshop remotely. In addition, you will be able to submit your questions online throughout the day. The moderators and speakers will do their best to answer as many questions as possible from the audience and online.
Send us your Questions in Advance
If you would like to submit a question in advance of the workshop, please complete the Question Form and send it to the Public Relations Division, EDQM. The deadline for receipt of questions is 14 September.