Legal constraints with regard to MAPPs (D2.08)

A broad review of the main legal areas governing medicinal product development, approval and market access, in the context of MAPPs, was undertaken - except any potential impact of MAPPs on Intellectual Property and Regulatory Exclusivity Rights that will be analysed by D3.06 working group, within Work Package 3. The two documents should be read and understood together.

Legal constraints with regard to MAPPs (D2.08) 2018-04-11T12:55:59+00:00

Tools and systems to guide appropriate use of medicinal products in twelve EU Member States (D2.07)

The objective of D2.07 was to provide an overview of which tools and systems are available at the national level to guide the appropriate use of medicinal products in EU Member States. This report looks at all tools/systems for guiding appropriate use at the national level, even if these may not be directly applicable in the context of a MAPPs-type pathway.

Tools and systems to guide appropriate use of medicinal products in twelve EU Member States (D2.07) 2018-04-11T13:17:54+00:00

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).

Joint workshop: tools and systems used for prescription control & the ethical and legal aspects of adaptive decision making (D2.07 & D3.09) 2018-04-11T14:20:03+00:00

Seamless Process and Decision Points of an Adaptive Pathway (D2.05)

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.

Seamless Process and Decision Points of an Adaptive Pathway (D2.05) 2018-04-11T14:34:09+00:00

Discussion paper on Engagement Criteria for MAPPs (D2.03)

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 (D2.03) 2018-04-11T13:24:11+00:00

Workshop: Selection Criteria for MAPPs – Exploring and aligning stakeholder needs (D2.03)

On the 29th of February, ADAPT SMART hosted an invitation-only multi-stakeholder workshop around selection criteria for MAPPs in Amsterdam, The Netherlands.

Workshop: Selection Criteria for MAPPs – Exploring and aligning stakeholder needs (D2.03) 2018-04-11T14:42:38+00:00

ADAPT SMART Glossary (D2.02)

The ADAPT SMART glossary provides working definitions for common terms relevant for the consortium and includes references. The glossary is based on the input from members of the ADAPT SMART consortium representing different stakeholder groups. The definitions are based on relevant legislation or literature sources and written in the context of the ADAPT SMART project; where applicable, [...]

ADAPT SMART Glossary (D2.02) 2018-04-11T13:25:31+00:00