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30 10, 2014

Topic of the month

By | October 30th, 2014|Topic of the Month|0 Comments

Draft Document: European Pharmacopoieia on Raw Materials for the production of cell-based and gene therapy medicinal products (Pa/PH/Exp. RCG/T (14) 5 ANP) out for comments   The European Pharmacopoieia has [...]

22 09, 2014

Successful GMP Workshop in Hannover (12.September.2014)

By | September 22nd, 2014|Project|0 Comments

A GMP workshop "Manufacturing of cell-based therapies: From bench to bedside" took place this month in Hannover. 20 participants from 7 different countries attended this successful workshop. AGORA was represented by Prof. [...]

19 08, 2014

bbb-Workshop on September 10th

By | August 19th, 2014|Upcoming events|0 Comments

  Introduction to Regulatory Affairs- from Bench to Clinic With a focus on CMC* requirements during development of biopharmaceutical products Link: http://www.healthcapital.de/fileadmin/cluster/Fotos/News_2014/Einladung_und_Programm_bbb-Zulassungsworkshop.pdf ? Where?: Beuth Hochschule für Technik Berlin; Haus Gauß, Raum [...]

29 07, 2014

ATMP Workshop: how to bring cell-based medicinal products successfully to the market

By | July 29th, 2014|Upcoming events|0 Comments

  Advanced Therapy Medicinal Products: how to bring cell-based medicinal products successfully to the market Workshop Programme 11 September 2014 Maritim Internationales Congress Centrum, Dresden, GERMANY Link: http://www.dgti-kongress.de/en/programm/eu-atmp-workshop-by-cat/  This workshop [...]

23 07, 2014

AGORA June 2014 Newsletter

By | July 23rd, 2014|Project|0 Comments

Here is the second edition of the AGORA project Newsletter, June 2014 [custom_button text="Click here to download the .PDF document" title="Click here to download the .PDF document" url="http://agora-gmp.org/wp-content/uploads/2014/07/agora_newsletter_2_jun14.pdf" size="large" bg_color="#FF5C00" [...]

1 07, 2014

Update and Request for Comments: Reflection Paper on the Classification of ATMPs

By | July 1st, 2014|Blog Articles|0 Comments

The EMA Expert Committee on ATMPs, CAT, has issued a new version of their reflection paper on ATMPs, updating the document to reflect the current thinking of the CAT on [...]

26 06, 2014

Regulatory Survey

By | June 26th, 2014|Survey|0 Comments

Academic GMP facilities play a pivotal role in the development of advanced therapy medicinal products (ATMPs). Until now, only a few ATMPs have received marketing authorization but many (new) ATMPs [...]

24 06, 2014

Topic of the Month: “EC Report on EU Regulation”. Please give your opinion!

By | June 24th, 2014|Blog Articles|0 Comments

Stakeholders to comment on the European Commission’s Report: The European Commission has adopted a Report on the application of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products (“ATMP [...]

24 06, 2014

TUM Cells: First Manufacturing Licence Granted

By | June 24th, 2014|Project|0 Comments

TUM Cells, the newly established GMP facility of the TU Munich, is now being granted their first manufacturing license, in this case a gene transfer medicinal product that will be [...]

20 06, 2014

PharmaCell to finalize purchase of cell therapy production facility

By | June 20th, 2014|Project|0 Comments

PharmaCell B.V. announced on June 2nd, 2014 that it finalized its purchase of the state-of-the-art cell therapy production facility from TiGenix NV, a leading European cell therapy company. For more [...]