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19 01, 2016

SUMMARY OF AGORA ACHIEVEMENTS

By | January 19th, 2016|Project News|0 Comments

AGORA: "Advanced Therapy Medicinal Product Good Manufacturing Practice Open Access Research Alliance" , Grant Agreement No. 602366 The AGORA project funding ended in October 2015 but it leaves behind an important legacy. [...]

19 01, 2016

Farewell Letter AGORA

By | January 19th, 2016|Project News|0 Comments

FP7 Grant Agreement No. 602366 "Advanced Therapy Medicinal Product Good Manufacturing Practice Open Access Research Alliance" The AGORA project funding ended in October 2015 but it leaves behind an important [...]

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 [...]

4 12, 2015

3rd International Symposium on Adoptive T Cell Therapy 17th/18th March 2016

By | December 4th, 2015|Old Articles|0 Comments

DFG SFB TR36 3rd International Symposium 17th - 18th March 2016 Klinikumrechts der Isar, Munich, Germany Symposium SFB TR 36 2016 Confirmed Speakers: Abken, Hinrich - Cologne, Germany; Bonini, Chiara [...]

3 11, 2015

Register now to the CDDF-ITCC-SIOPE 4th Paediatric Oncology Conference, 20 & 21 January 2016, Brussels (BE)

By | November 3rd, 2015|Upcoming events|0 Comments

Following on from three successful editions, the Cancer Drug Development Forum (CDDF), in partnership with the Innovative Therapies for Children with Cancer (ITCC) and the European Society for Paediatric Oncology [...]

15 09, 2015

Open Consultation on GMP for ATMPs

By | September 15th, 2015|Old Articles|0 Comments

Targeted stakeholder consultation on the development of Good Manufacturing Practice for Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation 1394/2007 Targeted stakeholders All stakeholders involved in the development, [...]

8 07, 2015

QP Training Session (AGORA – ECA – ISCT) at the ISCT 2015 Regional Europe Meeting

By | July 8th, 2015|Project News|0 Comments

AGORA, ECA and ISCT organized a joint training session for QPs on ATMPs at the ISCT Regional Europe Meeting, hosted in Seville, Spain, 24-26 September, 2015. The QP training session [...]

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

23 06, 2015

Implementation of academic ATMP in clinical practice in The Netherlands

By | June 23rd, 2015|Blog Articles|0 Comments

Advanced Therapy Medicinal Products (ATMPs), including gene (GTMP), cell (CTMP) and tissue-engineered products (TEP) can only be applied under European regulatory framework within: • A clinical study protocol • Hospital Exemption (HE) • Marketing Authorization (MA) [...]

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 [...]