Report on lessons learned from the conduct of the PoC feasibility assessments and implications for the sustainability plan (D8.20)

The goal of the IMI ConcePTION project is to build an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding. An important element in this ecosystem is the scientific study network. This study network aims to act as a single point of contact for any organisation that wants to conduct a study on medicines in pregnant or breastfeeding persons. The network should give access to a variety of data sources from different countries as well as registering different types of data.

To be able to launch the ecosystem after the conclusion of the IMI ConcePTION project, it is important to gather as much experience with the envisioned model during the lifespan of the project. For this purpose, the consortium has initiated two feasibility studies in order to ‘test’ the study network and to act as a learning device.

In light of the successful implementation of the first two studies with Data Access Providers (DAPs) and the need for continued improvement, the following recommendations and next steps have been identified to optimize the management process of study requests and DAPs:

• Identify incentives for DAPs and Data Requestors.
• Develop a framework agreement with DAPs.
• Develop a quality control framework for DAP Onboarding.
• Identify a Standing Committee and study fit-assessment criteria.
• Develop of a sustainable financial model for post-IMI funding phase.
• Implement a legal frameworks for post-IMI phase.
• Capture learning from conducted studies.

The recommendations form important input for the sustainability discussions in the IMI ConcePTION project during the coming period.