Recording Online Training: GMP for ATMPs

Recording Online Training: GMP for ATMPs

Costs

ECA-Member*: EUR 1490,--
Non ECA Member*: EUR 1690,--
EU/GMP Inspectorates*: EUR 845,--
APIC Member Discount*: EUR 1590,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

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

Speaker

Dr Rainer Gnibl, Government of Upper Bavaria, GMP Inspector

Background

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.

Target Group

This seminar is aimed at all persons who are involved in
  •  development
  •  marketing authorisation
  •  manufacturing
  •  quality assurance
  •  quality control
  •  or inspection/auditing
of ATMPs.
 

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

This recorded course and accompanying live panel discussion with regulatory agency speakers and experts from university, small and medium industry, and laboratory will feature 17 lectures that provide both a comprehensive overview of the guidance content.

 Your questions will be answered by the experts during the live discussion on 17 June 2021.

The Lectures and approx. time:
  1. EU-GMP for Advanced Therapy Medicinal Products (ATMPs) - an Overview  (20 min.)
  2. Pharmaceutical Quality System  (25 min.)
  3. Quality Risk Management   (30 min.)
  4. Personnel   (35 min.)
  5. Premises & Zone Concept   (60 min.)
  6. Equipment   (12 min.)
  7. Qualification  (45 min.)
  8. Environmental Monitoring  (40 min.)
  9. Materials   (59 min.)
  10. Production   (85 min.)
  11. Validation   (60 min.)
  12. Documentation   (45 min.)
  13. Quality Control   (35 min.)
  14. QP Certification & Batch Release   (75 min.)
  15. Outsourced Activities   (20 min.)
  16. Quality Defects & Product Recalls   (20 min.)
  17. Specific Products & Processes   (20 min.)

 

Recording from 14 June 2021

Duration of Recording: Appr. 11h 19min

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