China GMP and Registration for APIs - Online Training Recording

Costs

*ECA-Member:**	EUR 490,--
*Regular Fee:**	EUR 590,--
*EU/GMP Inspectorates:**	EUR 490,--
*APIC Member Discount:**	EUR 540,--

(All prices excl. VAT)

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
Francois Vandeweyer, Freelance Consultant, formerly Janssen Pharmaceuticals

Objectives

In a relatively short period of time, China has become the leading global supplier of APIs in terms of volume. China is the world’s leading producer and exporter of active pharmaceutical ingredients (APIs) by volume, accounting for 20% of total global API output. According to WHO China produces over 2000 APIs, with annual production capacity exceeding 2 million tons.¹

China first introduced GMP in 1988, and the latest GMP regulations are the 2010 revised edition of Good Manufacturing Practice for Pharmaceutical Products (with effect from 1 March 2011). While CFDA is responsible for developing regulations and standards for GMP, it is mainly provincial and local authorities that are responsible for inspection and certification.¹

The understanding of GMP and Registration Procedures for APIs are thus important to know and understand.

This online training course provides an overview of the legal requirements regarding APIs in China.

¹Source: WHO Report https://www.who.int/phi/publications/ 2081China020517.pdf?ua=1

Target Group

This online training course 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.

Training Course Documentation and Certificate:

The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

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

China Current View on Drug GMP
Francois Vandeweyer

Chinese GMP main topics
Chinese Drug GMP on site inspection focus points
Chinese GMP annexes with focus on Biologicals
Chinese quality management and equipment strategy to compete with the West

Recording of 20 October 2020

Duration of Recording: 1 h 38 min

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