Workshop on the clinical investigation of new medicines for the treatment of multiple sclerosis

• Date:
  Thursday, 17 October 2013, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The main goal of the workshop is to make sure that in the revision of the multiple-sclerosis guideline, the European Medicines Agency can take the most up-to-date, state-of-the-art scientific developments in multiple sclerosis into consideration, as well as the positions of experts in the field on the main topics in the guideline.

Documents

Agenda - Programme - European Medicines Agency workshop on the clinical investigation of new medicines for the treatment of multiple sclerosis

Reference Number: EMA/263897/2013

Summaries of the presentations - European Medicines Agency workshop on the clinical investigation of new medicines for the treatment of multiple sclerosis

Reference Number: EMA/576938/2013

Invitation for expressions of interest - European Medicines Agency workshop on the clinical investigation of new medicines for the treatment of multiple sclerosis

Reference Number: EMA/346872/2013

Presentation - Disability assessment: can we combine responsiveness and clinical relevance? (Bernard Uitdehaag)

Presentation - Cognition and fatigue as major determinants of disability (Bernd C. Kieseier)

Presentation - Optical coherence tomography: A role in monitoring multiple sclerosis (Celia Oreja-Guevara)

Presentation - New perception of disability – including cognition, fatigue, pain and other impairments related to multiple sclerosis (Diego Cadavid)

Presentation - Patient-reported outcomes, biomarkers and novel methodologies, and their role in the development of new multiple sclerosis medicines (Frank Dahlke)

Presentation - The staggered two-step approach for treatments with profound effect on immunity (Gavin Giovannoni)

Presentation - Critical review of outcomes used in MS clinical trials (George Ebers)

Presentation - The new outcome measures in MS: possible better ways to assess disability that overcome the limitations of the EDSS (Gilmore O'Neill)

Presentation - Changes in Patient Population - Insufficient Treatment Response (Gordon Francis)

Presentation - The proposed ‘two-step approach’ for MS treatments with a significant effect on immunity (Hideki Garren)

Presentation - Multi-arm trials with repurposed drugs in progressive MS (Jeremy Chataway)

Presentation - Approaches to advancing patient focussed outcomes assessment in clinical trials (Jeremy Hobart)

Presentation - Treatment guidelines for relapsing MS and the ‘two step approach’ for disease modifying therapy (Klaus Schmierer)

Presentation - How to evaluate medications in Multiple Sclerosis when placebo controlled RCTs are not feasible (Luca Massacesi)

Presentation - Design strategies to minimise the use of placebo in MS clinical trials (Maria Pia Sormani)

Presentation - Assessing benefit/risk profile of novel immunomodulatory drugs with significant efficacy but potential risks. What data should be presented at MAA? (Michael Panzara)

Presentation - Issues regarding use of placebo in multiple sclerosis drug trials (Peter Scott Chin)

Presentation - Clinical development issues in progressive multiple sclerosis(Volker Knappertz)

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