European Medicines Agency (EMA) / European Biopharmaceutical Enterprises (EBE) fifth annual regulatory conference on optimising the development of advanced therapies to meet patient needs
Date:
16/12/2016
Location:
CCT venues, 40 Bank Street, Canary Wharf, London E14 5NR
The fifth annual regulatory conference organised by European Biopharmaceutical Enterprises (EBE), with the collaboration of the European Medicines Agency (EMA), will discuss initiatives to improve advanced therapy medicinal products (ATMPs) access to patients, specific requirements for gene-therapy medicinal products, meeting specific standards for development and commercialisation of ATMPs and listening to the stakeholders of innovative medicines. It will bring together speakers and panellists from a broad range of public and private stakeholders, including patients, academia, regulators, investors and industry.
-
List item
Summary report - Fifth annual regulatory conference organised by EBE, in collaboration with the European Medicines Agency (EMA) “Optimising the development of ATMPs to meet patient needs” (PDF/198.4 KB)
First published: 07/02/2017
Last updated: 07/02/2017 -
List item
Agenda - EMA / European Biopharmaceutical Enterprises (EBE) fifth annual regulatory conference on optimising the development of advanced therapies to meet patient needs (PDF/81.86 KB)
First published: 20/10/2016
Last updated: 19/12/2016 -
List item
Presentation - Initiatives to improve ATMPs access to patients (Ana Hidalgo-Simon) (PDF/381.53 KB)
First published: 19/12/2016
Last updated: 19/12/2016 -
List item
Presentation - Innovative Medicines Initiative (IMI) (Salah-Dine Chibout) (PDF/1.92 MB)
First published: 19/12/2016
Last updated: 19/12/2016 -
List item
Presentation - US FDA expedited programs and expanded access (Ke Liu) (PDF/743.03 KB)
First published: 19/12/2016
Last updated: 19/12/2016 -
List item
Presentation - Environmental risk assessments: EU clinical trials with GMO-based ATMPs (Ann Gorman) (PDF/220.61 KB)
First published: 19/12/2016
Last updated: 19/12/2016 -
List item
Presentation - Gene therapy ATMPs: High Council for the biotechnology’s scientific committee expertise for contained use and deliberate release (Nils Braun and Jean-Christophe Pagà¨s) (PDF/213.55 KB)
First published: 19/12/2016
Last updated: 19/12/2016 -
List item
Presentation - National competent authorities experience with environmental risk assessment (ERA) before setting clinic trials: Procedure and experience in Germany (Brigitte Anliker) (PDF/507.87 KB)
First published: 19/12/2016
Last updated: 19/12/2016 -
List item
Presentation - Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products – an update (Christiane Niederlaender) (PDF/161.5 KB)
First published: 19/12/2016
Last updated: 19/12/2016 -
List item
Presentation - Challenges of developing cell and gene therapy products in Europe (Sven Kili) (PDF/1.41 MB)
First published: 19/12/2016
Last updated: 19/12/2016 -
List item
Presentation - Update on investigational ATMP concept paper guideline (Ilona Reischl) (PDF/472.34 KB)
First published: 19/12/2016
Last updated: 19/12/2016 -
List item
Presentation - Chemistry, manufacturing, and control (CMC) development and manufacturing challenges (Steven Howe) (PDF/961.34 KB)
First published: 19/12/2016
Last updated: 19/12/2016 -
List item
Presentation - Listening to the stakeholders of innovative medicinal products: The patient perspective (Martine Pergent) (PDF/2.36 MB)
First published: 19/12/2016
Last updated: 19/12/2016 -
List item
Presentation - Viewpoint from a health care professional (Christoph Hoeller) (PDF/682.37 KB)
First published: 19/12/2016
Last updated: 19/12/2016 -
List item
Presentation - The investor’s perspective (Joep Muijrers) (PDF/55.81 KB)
First published: 19/12/2016
Last updated: 19/12/2016 -
List item
Presentation - Listening to the stakeholders of innovative medicinal products – Payer viewpoint (Anna Bucsics) (PDF/850.14 KB)
First published: 19/12/2016
Last updated: 19/12/2016