Published August 17, 2021 | Version v1
Project deliverable Open

Report explaining the regulatory procedures, their scientific requirements, priorities and decision-making pathways regarding the use of medicines in pregnancy and lactation (D6.2)

  • 1. EMA
  • 2. TAKEDA
  • 3. i-HD


This deliverable builds on information gathered in Deliverable 6.1 in the space of engaging with Regulators and outlines the steps being proposed within ConcePTION as we look to engage with the regulatory authorities. It also summarizes the work that has been done in producing a project-wide Glossary that has been developed for consortium wide use.



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ConcePTION – Building an ecosystem for better monitoring and communicating of medication safety in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation 821520
European Commission