European Medicines Agency (EMA) / European Biopharmaceutical Enterprises (EBE) fifth annual regulatory conference on optimising the development of advanced therapies to meet patient needs

• Date:
  Friday, 16 December 2016, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

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”

Agenda - EMA / European Biopharmaceutical Enterprises (EBE) fifth annual regulatory conference on optimising the development of advanced therapies to meet patient needs

Presentation - Initiatives to improve ATMPs access to patients (Ana Hidalgo-Simon)

Presentation - Innovative Medicines Initiative (IMI) (Salah-Dine Chibout)

Presentation - US FDA expedited programs and expanded access (Ke Liu)

Presentation - Environmental risk assessments: EU clinical trials with GMO-based ATMPs (Ann Gorman)

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)

Presentation - National competent authorities experience with environmental risk assessment (ERA) before setting clinic trials: Procedure and experience in Germany (Brigitte Anliker)

Presentation - Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products – an update (Christiane Niederlaender)

Presentation - Challenges of developing cell and gene therapy products in Europe (Sven Kili)

Presentation - Update on investigational ATMP concept paper guideline (Ilona Reischl)

Presentation - Chemistry, manufacturing, and control (CMC) development and manufacturing challenges (Steven Howe)

Presentation - Listening to the stakeholders of innovative medicinal products: The patient perspective (Martine Pergent)

Presentation - Viewpoint from a health care professional (Christoph Hoeller)

Presentation - The investor’s perspective (Joep Muijrers)

Presentation - Listening to the stakeholders of innovative medicinal products – Payer viewpoint (Anna Bucsics)