Pink Sheet is part of the Business Intelligence Division 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 To Address Industry Concerns in Revised Signal Management Guideline

Executive Summary

The European Medicines Agency is examining the “constructive and pragmatic” feedback it has received on its revised guideline on safety signal detection, which aims to help companies fulfil their new legal obligation to monitor EudraVigilance data and report validated signals within strict timelines.

Advertisement

Related Content

Pharma Buoyed By Preview Of 'Helpful Changes' To EMA's Signal Management Guide
EMA Rolls Out Monthly Time Slots To Stagger Registration To Revamped EudraVigilance Database
Modernized Pharmacovigilance Database Nears In Switzerland
EU Generic Industry Group Looks At Radical Options To Simplify Pharmacovigilance Tasks
Pharma Firms Fear Diminished Role In Revised EU Signal Detection Guideline

Topics

Advertisement
UsernamePublicRestriction

Register

PS119926

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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