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EMA hosts a Workshop on Adaptive Pathways

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.

EMA hosts a Workshop on Adaptive Pathways 2017-06-20T11:17:45+00:00

Press release: IMI’s ADAPT SMART Kick-Starts 2017 by Putting Stakeholders at the Centre

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.

Press release: IMI’s ADAPT SMART Kick-Starts 2017 by Putting Stakeholders at the Centre 2017-06-20T11:17:45+00:00

ADAPT SMART in 2017 – Putting Stakeholder Opinions at the Centre of the Process

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.

ADAPT SMART in 2017 – Putting Stakeholder Opinions at the Centre of the Process 2017-06-20T11:17:45+00:00

ADAPT SMART’s Webinar Discusses Positive Developments and Remaining Challenges for 2017

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.

ADAPT SMART’s Webinar Discusses Positive Developments and Remaining Challenges for 2017 2017-06-20T11:17:45+00:00

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).

Report by Charles River Associates: use of managed entry agreements for products with a conditional or exceptional authorisations 2017-06-20T11:17:45+00:00

Discussion paper on Engagement Criteria for 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.

Discussion paper on Engagement Criteria for MAPPs 2017-06-20T11:17:45+00:00

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.

ADAPT SMART Workshop: “Seamless pathway and the impact on decision making: Exploring and aligning stakeholder needs” 2017-07-10T11:17:17+00:00