Webinar Report: “Implementing Real World Data to Make Adaptive Pathways Work” On 18 October 2017, the ADAPT SMART consortium presented a webinar hosted by the Estonian Ministry of Social Affairs. The webinar was the final event of eHealth week, an international conference occurring as part of Estonia’s Presidency of the European Council, and discussed [...]
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25 Oct 2017 8:00 AM – 26 Oct 2017 3:30 PM CET Radisson Blu Steinentorstrasse 25 4001 Basel Switzerland
18th October 2017, 15.15-16.15 CET Adaptive Pathways (or Medicine Adaptive Pathways to Patients (MAPPs)) potentially provide a tool to place new, innovative medicines into the market for those patients at greatest unmet need. This webinar will discuss how Eastern European countries are implementing Real World Data tools that can be used to provide the data infrastructure needed to make Adaptive Pathways work.
EMA answers to questions from industry partners in the ADAPT SMART consortium regarding the EMA Adaptive Pathways pilot project
EMA answers to questions from industry partners in the ADAPT SMART consortium regarding the EMA Adaptive Pathways pilot project Response: Adaptive Pathways is a concept that seeks to foster access to beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion. In so [...]
Joint workshop: Patient uncertainties and exploring the ethical and legal considerations of MAPPs (D3.04 & D3.08)
In order to continue the instructive discussions of the ADAPTSMART programme of work, on January 17th 2017, the ADAPT SMART consortium hosted a multi-stakeholder workshop on ‘Patient uncertainties and exploring the ethical and legal considerations of MAPPs’, bringing together two work streams - D3.04 and D3.08. This workshop comprised of 40 representatives including; European regulators, Health Technology Assessment (HTA) bodies, the pharmaceutical industry, patient organizations, health care professionals, and academics
Workshop: The Impact of Adaptive Pathways and Adaptive Access on Intellectual property and Regulatory exclusivity rights (D3.06)
On April 12th 2017, the IMI ADAPTSMART consortium hosted a multi-stakeholder workshop. Twenty-two representatives attended, including: medicine developers, independent IP and regulatory lawyers, payers, academics and policy makers.
Joint workshop: tools and systems used for prescription control & the ethical and legal aspects of adaptive decision making (D2.07 & D3.09)
On the 17th of January 2017, as part of its Annual Meeting, the ADAPT SMART consortium hosted a multi-stakeholder workshop on ‘Tools and systems used for prescription control and the ethical and legal aspects of adaptive decision making’. The topic of this workshop related to two different deliverables: D2.07 (focused on prescription control) and D3.09 (focused on ethical and legal aspects of adaptive decision making).
On April 19th, 2017, the ADAPT SMART Consortia, comprising over 30 international partners including regulators, patients, academia and industry, held its first public webinar to give an update on the project’s progress and milestones, as well as its efforts to incorporate the feedback of key stakeholders groups during the calendar year of 2017.
This report proposes a framework with pictographic representation of an adaptive pathway containing key moments, events and involved stakeholders, in each phase. This model is purposefully presented rather simplistically in this first evolution, acknowledging that there remain several questions to be answered – both unique to each individual potential medicine as well as to full implementation of an integrated adaptive pathway approach.
D1.02 aimed to analyse and monitor IMI and non IMI project outputs, and to perform a gap analysis of the wealth of evidence generation in the context of MAPPs. In other words, tools and methods developed by IMI and other EU projects, which could benefit MAPPs have to be identified. To this effect, a two-phase process was identified.