Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Review Identifies Opportunities To Help EMA Realize Full Potential Of RWE

Executive Summary

An EU review shows the great potential of regulator-led real-world evidence studies to address a range of research questions for regulatory decision making. It also provides learnings and recommendations for future improvements to the RWE framework being drawn up by the European Medicines Agency alongside the European medicines regulatory network.

You may also be interested in...

EMA’s Pediatrics Group To Focus On ‘Stepwise’ PIPs & Using RWE In 2024

The European Medicines Agency has drawn up an action plan for its pediatrics committee that will see existing initiatives, such as the introduction of a ‘stepwise’ approach to pediatric investigation plans, further developed this year.

EMA Makes Progress On Real-World Evidence ‘Use Cases’ With HTA Bodies & Payers

The European Medicines Agency is looking at how it can generate real-world evidence on multiple myeloma and non-small cell lung cancer using its new DARWIN EU platform so that the outcomes can also be of use for health technology assessment bodies and payers.

EMA Lays Out Plans For Routine Use Of Real-World Evidence

A panel of regulators overseeing the implementation of several big data projects within the EU medicines network has given details of real-world evidence integration pilots to be undertaken next year by various European Medicines Agency scientific committees.


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts