Registration opens for EMA workshop on the clinical investigation of medicines for the treatment of Alzheimer's disease

11 April 2014

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 Alzheimer's disease on 24-25 November 2014.

The Agency is organising this workshop following the public-consultation exercise on itsDraft concept paper on need for revision of the guideline on medicinal products for the treatment of Alzheimer's disease and other dementias - Revision 1. The concept paper was released for public consultation from October 2013 to January 2014. Based on the comments received, the Agency is currently revising the Guideline on the clinical evaluation of medicinal products intended for treatment of Hepatitis B - First version and expects to release a first draft for public consultation within the next few months.

Recent progress in understanding the neurobiology and pathophysiology of Alzheimer's disease as well as new research diagnostic criteria, including biomarkers, have had an impact on recent and future clinical development in this area.

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 treating Alzheimer's disease 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 of patients, regulators, pharmaceutical industry and independent experts. Topics on the agenda will include:

• the latest advances in the understanding of the pathophysiology of Alzheimer's disease and the discovery of disease-modifying treatment targets;
• the changing diagnostic criteria for Alzheimer's disease, including early and asymptomatic disease stages, and their impact on the clinical-trial design;
• the potential use of biomarkers and their temporal relationship with the different phases of Alzheimer's disease in different stages of drug development;
• the choice of outcome parameters and need for distinct assessment tools with regard to the different disease stages in Alzheimer's disease;
• the scientific and regulatory approaches to facilitating disease-modifying drug development and marketing authorisation in a global environment;
• the place for treatments for associated neuropsychiatric and other symptoms.

Expressions of interest should be sent to [e-mail] by 1 July 2014 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 in due course. The workshop will be publicly broadcasted live on the EMA website.