China GMP and Registration of APIs - Online Training Recording

Costs

*ECA-Member:**	EUR 590,--
*Regular Fee:**	EUR 690,--
*EU/GMP Inspectorates:**	EUR 590,--
*APIC Member Discount:**	EUR 640,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Marieke van Dalen, Global Regulatory Specialist, Aspen Oss, The Netherlands
Francois Vandeweyer, Freelance Consultant, Belgium, formerly Janssen Pharmaceuticals
Ellen Zandvoort, Aspen Oss, Customer & Regulatory Support Officer, The Netherlands

Objectives

China first introduced GMP in 1988, and since then the GMP regulations are revised and updated several times. Most of the existing GMP requirements and guidance documents were updated by the so called National Medical Products Administration (NMPA), China’s new Drug Regulatory Authority since 2018, and replace former Guidelines published by the CFDA (China Food and Drug Administration). In 2021, the NMPA published a new guideline in regard on the inspection system and GMP certificates, which influenced the certification procedure tremendously.

Also in 2021, the NMPA issued new guidelines with information relevant for changes in registrations of drug products, for administrative and for technical processes. To keep track with the mandatory guidance documents of the regulatory authority as well as the understanding of the GMP requirements and registration procedures for APIs are the prerequisites to register APIs in China.

This Live Online Training provides an overview of the regulatory and GMP requirements regarding APIs in China.

Target Group

This Live Online Training has been developed for all who are dealing with API Sourcing, Manufacturing, Quality Assurance and Regulatory Affairs.

Technical Details:

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.

Programme

API Registrations in China
Marieke van Dalen

Health authorities in China
The Chinese Drug Master File System
Bundled review
Specifics for the Chinese API Drug Master File
Common deficiencies

QC Testing: a China Specific Requirement
Ellen Zandvoort

The procedure for QC testing
Common observed hurdles with QC testing

China's Current View on Drug GMP
Francois Vandeweyer

Chinese GMP – general Topics
Chinese Drug GMP – on site inspection focus Points
Chinese GMP annexes with focus on Biologicals and the new Annex 13 for IMPs
Chinese quality management and equipment strategy to compete with the West

Recording from 2 November 2023

Duration of Recording: appr. 2h 15min

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