GMP for ATMPs - Guideline Overview - Online Training Recording

Relating to the increasing importance of advanced therapy medicinal products (ATMPs) the European Commission and the EMA published a joint document in 2007 with a proposal for a community regulatory framework on ATMPs.  With the additional comments of DG enterprise and the industry they issued an implementation plan for the ATMP regulation (Regulation (EC) No 1394/2007) with a date for application on 30 December 2008. In this time, the most ATMPs were in a phase of development and questions about scientific advice, registration and following marketing authorisation were more of interest than GMP issues. But with the increasing number of ATMPs and their development into phases with more GMP relevance, a more detailed guidance on Good Manufacturing Practice for Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation 1394/2007 became essential. Therefore, a first consultation on the development of such a GMP for ATMP guideline was started in July 2015.

Then, on 22 November, the European Commission adopted the “New Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products” which came in operation at 22 May 2018.

The new guideline includes requirements for ATMPs with a marketing authorisation as well as for advanced therapy medicinal products that are being tested or used as reference in a clinical trial (i.e. advanced therapy investigational medicinal products).The document should be the main document for the definition of the GMP requirements for ATMPs, so in the scope it states: “These Guidelines do not apply to medicinal products other than ATMPs. In turn, the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC4 and Article 63(1) of Regulation (EU) No 536/2014 do not apply to ATMPs, unless specific reference thereto is made in these.”

A look at the over 80 pages and  the table of content shows that the status as a stand alone guideline has made it necessary to include all important fields with relation to ATMPs which are normally covered for other medicinal products in the existing GMP guideline and its Annexes.

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.
 

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.