Registration open for workshop on the clinical investigation of medicines for the treatment of multiple sclerosis

20 June 2013

The European Medicines Agency (EMA) is inviting expressions of interest in attending its workshop on the clinical investigation of new medicines for the treatment of multiple sclerosis on 17 October 2013.

The Agency is organising this workshop following the public-consultation exercise on its revised Draft guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 2. The draft guideline was released for public consultation from October 2012 to April 2013.

With this workshop, the EMA is providing an opportunity for different stakeholder groups to come together and discuss the key scientific issues in the field.

The main goal of the workshop is to make sure that, while revising its guideline, the EMA can take the most up-to-date scientific developments in understanding and treatment of multiple sclerosis into consideration, as well as the positions of experts in the field on the main topics covered in the guideline.

The workshop will bring together representatives from the pharmaceutical industry, independent experts, patients and regulators. Topics on the agenda will include:

• new outcome measures in multiple sclerosis: possible better ways to assess disability that overcome limitations of the Expanded Disability Status Scale (EDSS);
• a new perception of disability, including cognition, fatigue, pain and other symptoms specifically related to multiple sclerosis;
• a staggered 'two-step approach' for treatments with a significant effect on immunity, including how to address safety concerns with new medicines with significant effect on immunity and what data on safety should be presented in initial marketing-authorisation applications;
• the changing multiple-sclerosis population and the definition of an 'insufficient treatment response', as well as their impact on the benefit-risk assessment of new medicines;
• the need for placebos in controlled trials in multiple sclerosis and how to design these trials;
• patient-reported outcomes, biomarkers and novel methodologies, and their role in the development of new multiple-sclerosis medicines.

Expressions of interest should be sent to [e-mail] by 16 August 2013 including name, company or affiliation, telephone number and e-mail address. Places will be allocated to ensure a fair representation of all stakeholder groups and organisations.

The Agenda will be published shortly. The workshop will be web-streamed.