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14 12, 2015

Hurdles in clinical implementation of academic ATMPs: A national evaluation

By | December 14th, 2015|News, Publications|0 Comments

Hurdles in clinical implementation of academic advanced therapy medicinal products: A national evaluation SOFIEKE DEWILDE1, LOUISE VELTROP-DUITS1, MEREL HOOZEMANS-STRIK2, THIRZA RAS3, JANINE BLOM-VEENMAN3, HENK-JAN GUCHELAAR1, MAARTEN ZANDVLIET1 & PAULINE MEIJ1 [...]

23 06, 2015

INTRODUCTORY ATMP DEVELOPMENT REGULATORY COURSE September 14-15, 2015 – Rome Italy

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

EATRIS & ISS PRESENT INTRODUCTORY ATMP DEVELOPMENT REGULATORY COURSE When?: September 14-15, 2015 Where?: Rome Italy Flyer with more information: ATMP course info and programme

9 06, 2015

EMA Consultation: Draft guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products

By | June 9th, 2015|News|0 Comments

The European Medicines Agency has released for public consultation a draft guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products. This guideline defines scientific principles and [...]

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 [...]

3 11, 2014

Draft: Functional specifications for the EU portal and EU database to be audited published for comments

By | November 3rd, 2014|News|0 Comments

One of the main features of the Clinical Trials Regulation (CTR) EU No 536/2014 repealing the Clinical Trials Directive is the creation of the EU portal and the EU database [...]