GMP for ATMPs - Streaming of Recorded Presentations AND Live Q&A

GMP for ATMPs - Streaming of Recorded Presentations AND Live Q&A

Course No 18544

All times mentioned are CEST.

Costs

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

(All prices excl. VAT)

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

Speakers

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

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.

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 valid on Thursday, 17 June, for the Panelist Discussion from 14.30 -16.30 h . You can log in there 30 minutes earlier.

Questions during the lectures should be send to atmp@gmp-compliance.org  They will be answered during the Live Panelist Discussion.

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.

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.)

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