18th January 2017 London, United Kingdom On the 18th of Janaury, ADAPT SMART hosted it’s Annual Meetings and General Assembly at the EMA in London.
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8th December 2016 London, United Kingdom On the 8th of December 2016, the European Medicines Agency has organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach.
ADAPT SMART’s General Assembly, held at the European Medicines Agency (EMA), agrees to focus its final year on incorporating stakeholder feedback into the development of Medicines Adaptive Pathways to Patients (MAPPs) tools and methodologies.
It is difficult to imagine, but the IMI’s ADAPT SMART project has been operational for eigtheen months, having launched officially at the EMA on September 4, 2015. ADAPT SMART is investigating the tools and (processes) interaction moments required for the use of Adaptive Pathways, but seeks a consensual, multi-stakeholder approach to the continuous lifespan evaluation of the evidence used in regulatory decision making for new therapies that address medical needs.
An Introduction to ADAPT SMART To download the slide deck, click here
On December 14th, IMI’s ADAPT SMART project heads and WP1-2-3 work package leads hosted an internal year-end webinar, updating on the project’s status and next steps for members of the consortium. Some 70 consortium members were guided through the project’s delivered first-year objectives and explained what will occur over next 12 months, until the end of ADAPT-SMART in December 2017.
Report by Charles River Associates: use of managed entry agreements for products with a conditional or exceptional authorisations
The European Federation of Pharmaceutical Industries and Associations (EFPIA) asked Charles River Associates (CRA) to undertake an interview programme to understand how managed entry agreements (MEA) have been used for products with Conditional Marketing Authorisations or Market Authorisations under exceptional circumstances as a proxy for Medicines Adaptive Pathways to Patients (MAPPs).
An issue of divergent views became apparent early in the course of the ADAPT SMART project, namely; to what kind of novel medicines and clinical scenarios/conditions should a MAPPs approach be applied? The ADAPT SMART consortium convened discussion fora with stakeholders to elaborate MAPPs engagement criteria that may be acceptable to all concerned within the existing legislation. In this paper, we summarize viewpoints from these discussions.
On the 29th of February, ADAPT SMART hosted an invitation-only multi-stakeholder workshop around selection criteria for MAPPs in Amsterdam, The Netherlands.
ADAPT SMART Workshop: “Seamless pathway and the impact on decision making: Exploring and aligning stakeholder needs”
6th July 2016
London, United Kingdom
On the 6th of July 2016 ADAPT SMART organised a one day workshops entitled "The Seamless pathway and the impact on decision making: Exploring and aligning stakeholder needs”. More than 30 representatives including; European regulators, Health Technology Assessment (HTA) bodies, the pharmaceutical industry, patient organizations, health care professionals and academics attended the workshop.