RD-ACTION / EMA / DG SANTE workshop: how European Reference Networks can add value to clinical research

• Date:
  Tuesday, 29 May 2018, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The main objective of this workshop organised by the European Medicines Agency (EMA), RD-ACTION (the European Joint Action for Rare Diseases) and the European Commission's Directorate General for Health and Food Safety (DG SANTE), is to explore how to work together with the European Reference Networks (ERNs) in the field of complex and rare diseases. The workshop will look at how EMA and ERNs can reinforce each other's efforts to encourage and facilitate research into new treatments for rare and low-prevalence complex diseases and how ERNs could be engaged in EMA activities. The first ERNs were launched in March 2017, involving more than 900 highly-specialised healthcare units from over 300 hospitals in 26 European Union countries. Presently, 24 ERNs are operational covering a large range of therapeutic areas.

Documents

Agenda - RD-ACTION, European Medicines Agency, and European Commission-DG SANTE workshop: how European Reference Networks can add value to clinical research

Reference Number: EMA/270801/2018

List of participants – RD-ACTION, European Medicines Agency, and European Commission-DG SANTE workshop: how European Reference Networks can add value to clinical research

Presentation - Introduction to the workshop: aims and expected outputs (Victoria Hedley)

Presentation - The European reference networks: a vision from inside (Maurizio Scarpa)

Presentation - ERNs and research - State of play from the European Commission perspective (Iiro Eerola)

Presentation - ERNs and research: state of play from the European Commission perspective (Helene Le Borgne)

Presentation - ERNs and research: state of play from the European Commission perspective - 'Snapshot' of ERNs and medicinal product point of view (Anneli Torronen)

Summary:

EMA / RD-ACTION / DG SANTE workshop: how European Reference Networks can add value to clinical research

Presentation - 'Snapshot' of transversal activities regarding ERNs and clinical research (Eduardo Là³pez Granados, Eileen Treacy, Daria Julkowska)

Summary:

EMA / RD-ACTION / DG SANTE workshop: how European Reference Networks can add value to clinical research

Presentation - Status quo of ERNs and clinical research: results of the ERN-wide survey (Luca Sangiorgi)

Presentation - The research potentials of MetabERN: a survey to investigate and prioritise actions (Jean Michel Heard)

Presentation - EURO-NMD case study (Teresinha Evangelista)

Presentation - ERN case studies: BOND ERN (Luca Sangiorgi)

Presentation - Case study: EURACAN clinical research (Stephane Lejeune)

Presentation - Patient expectations for meaningful engagement in ERN-related clinical research (Russell Wheeler)

Presentation - Working to protect public health in the European Union (Ivana Silva)

Presentation - Early engagement and support for medicine development (Stiina Aarum)

Presentation - Advanced therapy medicinal products (ATMPs) and ATMP Regulation (Patrick Celis)

Summary:

EMA / RD-ACTION / DG SANTE workshop: how European Reference Networks can add value to clinical research

Presentation - Clinical trials in the European Union: how European Reference Networks can add value to clinical research (Laura Pioppo)

Presentation - The European Medicines Agency Patient Registries Initiative (Xavier Kurz)

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