Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

UsernamePublicRestriction
UsernamePublicRestriction

EMA Consults On Using Registry Studies As RWE Source

Executive Summary

A draft EU guideline explains how disease registries can be used to supplement evidence in the pre-authorization phase and provide infrastructure for post-authorization evidence generation.

You may also be interested in...



EMA Guidance On Registry-Based Studies Due This Month

The European Medicines Agency is planning an October workshop to discuss its new guideline on registry-based studies and to discuss recent experience on aspects such as the use of a large registry for clinical trials.

Global Pharma Guidance Tracker – March 2021

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Major Review Of EU Pharmaceutical Legislation Kicks Off

The European Commission has launched the process for reshaping and addressing the long-standing weakness in the EU’s pharmaceutical legislation. It has listed in a roadmap the issues it wants to address as it considers policy options for reforms.

Topics

UsernamePublicRestriction

Register

PS143000

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

Cancel