ConcePTION - D6.1 - Cross-stakeholder engagement, endorsement and adoption - Roadmap

Sep 23, 2026

IMI ConcePTION develops methods and pipelines to generate evidence on safe and effective medicine use in pregnancy and breastfeeding, addressing ethical limitations of classical RCTs. Evidence is produced through real-world data sources, animal models and simulations, in vitro cell-based models, and expanded access to breast milk samples via milk biobanks. Stakeholders—including regulators, healthcare providers, and pregnant or lactating women—must decide how to appraise evidence from real-world and RCT sources. WP6 establishes engagement principles and a project-wide framework to align stakeholder needs with evidence generation.

LanguageEnglish

CategoryPresentations

FormatPDF

Pages44

Reading Time15 min

AccessFree to download

Executive Summary

Guiding principles for stakeholder engagement

Mapping stakeholder engagement needs

Guidelines to WPs for planning stakeholder engagement

Preparing for interaction with Regulatory Agencies

IMI2 821520-ConcePTION ConcePTION WP6 – Cross-stakeholder engagement, endorsement and adoption D6 . 1 Roadmap of planned project outputs, including qualification advice submissions, mapped to stakeholder needs and planned stakeholder interactions | Lead contributors | The European Institute for Innovation through Health Data [dipak.kalra@i-hd.eu](dipak.kalra@i-hd.eu)
Takeda Pharmaceuticals International AG (Zurich)
[christine.allan@takeda.com](christine.allan@takeda.com) | | --- | --- | | | | | Other contributors | European Forum for Good Clinical Practice The Synergist ASBL
Katholieke Universiteit Leuven
European Institute for Women’s Health Limited The European Medicines Agency
Janssen UCB Novartis Eli Lilly Teva | 821520 – ConcePTION – D6 .1 Document History | Version | Date | Description | Authors | | --- | --- | --- | --- | | V0.1 | 27 Feb 2020 | First draft, consolidating inputs from several contributors | Dipak Kalra | | V0.2 | 27 Feb 2020 | Comments | Christine Allan | | V0.3 | 27 Feb 2020 | Editorial and layout corrections, for WP review | Dipak Kalra | | V0.4 | 3 Mar 2020 | Incorporating feedback from WP6 members | Dipak Kalra | | V0.5 | 17 Mar 2020 | Incorporating feedback from MB members | Dipak Kalra | | VX.X | dd Mmm YYYY | Final Version | [Name]; [Name] | 821520 – ConcePTION – D6 .1 Abstract IMI ConcePTION is developing new methods and establishing new pipelines for the generation of evidence on the appropriate (safe and effective) use of medicines in pregnancy and during breastfeeding. It is doing this because there are ethical difficulties with generating evidence in the classical and well accepted method: through randomised controlled trials (RCTs) . This new evidence is largely being derived from real-world data (e.g. longitudinal observational studies, registries, electronic health records, pharmacovigilance), from animal models and simulations, in vitro human and animal cell-based models and by scaling up the availability of breast milk samples through a network of milk bio-banks. Many different stakeholders need to make critical decisions on the basis of clinical evidence, including regulators who might approve a new medicinal product or a new indication area or target population, healthcare providers who need to make prescribing decisions, pregnant and lactating women and their families who need to know what medicines they can trust and use with confidence. There is a history and tradition amongst the stakeholders of knowing how to appraise and base decisions on RCT evidence. There is far less experience and confidence in how to evaluate realworld evidence, on its own and in combination with RCT evidence, since each form brings different strengths and weaknesses. This project has placed the engagement of stakeholders as a high priority. This is firstly in order to understand the evidence gaps and decision-making challenges they presently face, and to match those to the kinds of evidence that the project is likely to be able to generate in its five years, and the ground it could lay down for future evidence generation. Secondly, it is important to engage with stakeholders on the kinds of new evidence that are being created in the project, in order to arrive atthe best possible consensus on how they should appraise and make use of it for decision-making. Work package 6 is dedicated specifically to stakeholder engagement, and this report is its first deliverable. It reports on how WP6 has defined guiding principles for stakeholder engagement, to apply to all of our meetings and materials that we circulate. We have established a framework for project-wide engagement with stakeholders, started to chart out the engagement aspirations and needs of each work package, and also helped the consortium to understand the formal channels that can be used with regulators such as the European Medicines Agency ( EMA) . 821520 – ConcePTION – D6 .1 Contents Executive Su

FAQs

What is the purpose of WP6 in the ConcePTION project?

WP6 is dedicated to stakeholder engagement and provides its first deliverable by defining guiding principles and a framework for project-wide engagement.

Why does ConcePTION focus on evidence beyond classical RCTs?

The project addresses ethical difficulties with generating evidence using RCTs and instead relies largely on real-world data, models, simulations, and scaled access to breast milk samples.

Who uses the generated clinical evidence and what decisions do they support?

Regulators, healthcare providers, and pregnant and lactating women and their families use the evidence to support decisions on approval, prescribing, and confidence in medicine use.

Sep 23, 2026

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