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19 05, 2015

1 June 2015 – AGENDA PDA Europe pre-meeting open session for AGORA – Amsterdam, The Netherlands

By | May 19th, 2015|Project|0 Comments

On 2-3 June 2015 Amsterdam will host the 2015 PDA Europe Advanced Therapy Medicinal Products Conference. In cooperation with the AGORA project, PDA Europe offers on 1 June a pre-conference [...]

5 05, 2015

4 – 6 November 2015: “ATMP 2015 – Issues and Challenges from Bench to Bedsite”, Tutzing, Germany.

By | May 5th, 2015|Project|0 Comments

Dechema biotechnologie organizes a conference titled: "ATMP 2015 – Issues and Challenges from Bench to Bedsite Production, analytics & regulatory aspects of cell-based therapies." The conference takes place in Tutzing, Germany [...]

4 05, 2015

29-30 June 2015: 2nd European Interdisciplinary Summit Conference 2015 – Berlin

By | May 4th, 2015|News|0 Comments

The second European Interdisciplinary Summit Conference "Regenerative Medicine in Europe: building a concept for strategic integration across Europe" takes place in Berlin. Date: 29-30 June Venue: Berlin-Brandenburgische Akademie der Wissenschaften [...]

23 04, 2015

Revised GMP chapter published – Annex 15 Qualification and Validation

By | April 23rd, 2015|News, Project News|0 Comments

The EC published a revised version of annex 15 which will come in effect as of October 1st 2015. The chapter has been extended from 11 to 16 pages and [...]

23 04, 2015

EU Commission published guidelines for risk assessment to ascertain GMP for excipients

By | April 23rd, 2015|News|0 Comments

On march 21st 2015 the EU published new guidelines on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (2015/C [...]

23 04, 2015

ImmunoCellular Therapeutics chooses PharmaCell as Contract Manufacturing partner for its Phase III program in Europe

By | April 23rd, 2015|News|0 Comments

Maastricht – March 19, 2015 – PharmaCell B.V., announced today that it finalized an agreement with ImmunoCellular Therapeutics Ltd. to support its pivotal phase III clinical trial in Europe with [...]

19 04, 2015

Gene Therapy Congress: 2-3 December 2015, Brussels, Belgium

By | April 19th, 2015|News|0 Comments

Informa's 2nd Annual Gene Therapy Congress will take place in Brussels, Belgium. When? 2 - 3 December 2015, Where?: Sheraton Brussels Airport Hotel For more information and registration use the [...]

12 03, 2015

New tools for ATMPs

By | March 12th, 2015|News, Project, Publications|0 Comments

Hannover Medical School, Germany, received the manufacturing license for Cytomegalovirus (CMV)-specific T cells in April 2014 (Tischer et al. 2014) and for Epstein Barr (EBV) and Adenovirus (ADV) specific T [...]

17 02, 2015

AGORA Newsletter 4, February 2015

By | February 17th, 2015|Project|0 Comments

The fourth edition of the AGORA project newsletter is now available to download. AGORA Newsletter February 2015

12 02, 2015

EMA consultation: Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal products- open for comments

By | February 12th, 2015|Publications, Uncategorized|0 Comments

The EMA has released for public consultation a concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal products. The [...]