The regulations governing research in Europe is complex and changing. In an attempt to make keeping up with current regulations as easy as possible you will find in these pages information on EU-wide and national organisations with a remit for regulation as well as relevant documents and updates.
Disclaimer! ESGCT has compiled this page for its members as helpful information. The European union legislation published in the paper version of the 'official Journal of the European Communities' is the only one to be deemed as official.
Draft guideline on Safety and Efficacy Follow-up - Risk Management of Advanced Therapy Medicinal Products.
The guideline is released for public consultation. Please, send comments to Dr Jan Petracek at jan.petracek@emea.europa.eu by 15th August 2008.
While EMEA welcomes questions on its activities and the regulatory framework within which it operates, specific questions on the interpretation of GMP requirements should be addressed, ideally by the Qualified Person, directly to the relevant supervisory authority of the Member State in which the manufacturing authorisation holder is located. Manufacturers based in third countries should contact the authority supervising the authorised importer.
Documents of interest:
http://www.emea.europa.eu/Inspections/GCPgeneral.html
NORTH AMERICA REGULATORY AGENCY
The Center for Biologics Evaluation and Research (CBER) of the US Food and Drug Administration (FDA)
National Institutes of Health
FDA - CDER - Guidance Documents
Non-viral genetic therapy strategies for the treatment of ataxia telangiectasia
James Grey received the ESGCT-sponsored prize for best poster presentation at the British Society for Gene and Cell Therapy (BSGCT) Annual Conference, which took place from 19-21 June 2019. Read about his winning presentation here!
Gene therapy for thrombotic thrombocytopaenic purpura
Robyn Bell received the ESGCT-sponsored prize for best oral presentation at the British Society for Gene and Cell Therapy (BSGCT) Annual Conference, which took place from 19-21 June 2019. Read about her winning presentation here!
CRISPR-Cas9 genome editing - molecular scissors a bit too sharp?
Grégoire Cullot received the ESGCT-sponsored prize for best oral presentation at the Société Française de Thérapie Cellulaire et Génique (SFTCG) Thematic Day on Viral Vectors, which took place on 17 May 2019 in Paris. Read about his winning presentation here!
Dgkk as a new therapeutic target in the Fmr1-KO murine model of Fragile X
Karima Habbas received the ESGCT-sponsored prize for best poster at the Société Française de Thérapie Cellulaire et Génique (SFTCG) Thematic Day on Viral Vectors, which took place on 17 May 2019 in Paris. Read about her winning presentation here!