GMP for ATMPs - A Detailed View at the European Guidelines
Streaming of Recorded Presentations AND Live Q&A
Im Auftrag der ECA Academy

GMP for ATMPs - A Detailed View at the European Guidelines Streaming of Recorded Presentations AND Live Q&A Im Auftrag der ECA Academy

Seminar Nr. 18544

All times mentioned are CEST.

Kosten

Dieses Seminar hat leider schon statt gefunden. Eine Anmeldung ist deshalb nicht mehr möglich. Für viele Seminare sind allerdings Aufzeichnungen verfügbar, die Sie jederzeit bestellen und anschauen können. Diese Aufzeichnungen finden Sie in einer themensortierten Liste. Selbstverständlich können Sie aber auch das folgende Kontaktformular nutzen, um uns Ihre Anfrage zu senden.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Speaker and Panelist:
Dr Rainer Gnibl, Government of Upper Bavaria, GMP Inspector

Further Panelists:
Dr Sabine Hauck, Leukocare, QP and Chair of ECAs ATMP Interest Group
Dr Andrea Hauser, University Regensburg, Vice Chair of ECAs ATMP Interest Group
Dr Rüdiger Alt, Manager Quality Assurance / Qualified Person ATMP, Novartis
Dr Thomas Meindl, Labor LS
Stefan Gärtner, Labor LS

Hintergrund

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.

Zielgruppe

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

How it works

As a participant you will receive two links, one for streaming the recorded presentations and one for the live WebEx Panel Discussion in which your submitted questions will be answered.

  • The first link is valid from Monday, 14 June, until Wednesday, 16 June. During these days, you can log in at any time and stream the lectures.
  • The second link is for the Panelist Discussion and is valid on Thursday, 17 June, from 14.30 -16.30 h . You can log in 30 minutes before the start .

Questions to be answered at the live Q&A Session should be send to atmp@gmp-compliance.org.

For the Live Online Panel Discussion on 17 June, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and e-mail address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

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.)

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