The European Medicines Agency (EMA) in collaboration with the European Commission
is organising a workshop on 8 December 2016 to gather the views of stakeholders on the adaptive pathways approach for medicine development.
The registration is now closed but you can follow a live broadcast of the workshop by clicking on the ‘multimedia’ tab on the event page.
The workshop will bring together a broad range of stakeholders, including representatives of healthcare professionals, patients, health technology assessment (HTA) bodies, payers, regulators and medicine developers.
In light of the practical experience gained during a pilot project which ran from March 2014 to July 2016, workshop participants will discuss the key aspects of adaptive pathways and the areas that need to be further explored. Topics to be discussed include:
- patients’ and healthcare professionals’ perspectives on addressing patients’ needs through adaptive pathways;
- knowledge generation throughout a medicine’s lifespan;
- from bench to bed: involvement of all relevant parties in the delivery of medicines for unmet medical needs.
More details on the workshop’s sessions and speakers are provided in the agenda for the meeting.
Adaptive pathways can be defined as a planned approach to bringing a medicine to patients in a progressive manner. Under this approach, the medicine will first be authorised in a patient population that is likely to benefit most from the medicine. Then, additional evidence is gathered over time, potentially resulting in changes to the marketing authorisation reflecting the expanded knowledge acquired.
EMA’s pilot project explored the practical implications of the adaptive pathways concept with medicines under development. A report highlighting the key learnings of the pilot and the areas for further reflection identified is available.
Individuals interested in tweeting on this event are invited to use the hashtag#AdaptivePathways.