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

UsernamePublicRestriction

EU Makes ISO Format Mandatory For Side-Effect Reporting From June 2022

New Standard Offers Improved Quality Of Data Collected

Executive Summary

Based on the operational experience gained using the new international standard for reporting suspected adverse reactions in EudraVigilance, the EU has decided to set a date for its mandatory use.

You may also be interested in...



EU To Tighten Up Some Pharmacovigilance Requirements

The European Commission is consulting on a range of proposals to overhaul a nine-year-old regulation on drug safety reporting procedures.

Danish Agency To Buy New Pharmacovigilance System

Rather than develop a new drug safety monitoring system from scratch, the Danish Medicines Agency is looking for a readymade solution.

EU Extends Pilot Of New Drug Safety Reporting System

Testing of the enhanced EU drug safety reporting system, EudraVigilance, is to be extended beyond February in an effort to gain more information on how stakeholders are finding the new requirements.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS141503

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