EMA Workshop on Adaptive Pathways

14 October 2016 527 Views
EMA Workshop on Adaptive Pathways

On 8th December 2016, the European Medicines Agency (EMA) will host a workshop to gather stakeholder views on the adaptive pathways approach.

Registration to the workshop is open until 1st November 2016. The workshop will also be broadcast live on the EMA website.

The adaptive pathways approach is seen as a progressive approach to bringing a medicine to patients. Under the approach, medicines are first authorised in a small group of patients, which is likely to benefit most from the medicine. Over time additional evidence is gathered, which allows the marketing authorisation to be adapted and extended as necessary to cover other patients.

The adaptive pathways approach is especially useful in developing medicines in therapeutic areas where evidence generation is challenging, such as infectious diseases, Alzheimer’s disease, degenerative diseases, and rare cancers.

The workshop is intended for any interested stakeholders, including representatives of healthcare professionals, patients, health technology assessment bodies, regulators and medicine developers. Topics discussed during the workshop will include the best ways of addressing patients’ needs through adaptive pathways, knowledge generation throughout a medicine’s lifespan, and involvement of all relevant parties in the delivery of medicines for unmet medical needs.

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