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


UK MHRA Takes Companies To Task Over Trial Safety Information Reporting

Executive Summary

Sponsors of clinical trials in the EU have recently been inundated with objections from regulators for incorrectly managing their clinical trial reference safety information, which in turn has resulted in these trials being significantly delayed. A UK MHRA inspector discusses some of the common issues identified during inspections on this front.

You may also be interested in...

Incorrect Use Of Reference Safety Info Still An Issue, Says UK MHRA

UK good clinical practice inspectors are continuing to detect critical shortcomings relating to clinical trials safety and the management of reference safety information. 

How To Manage Pharmacovigilance Inspections In A Globalized World

As companies undergo pharmacovigilance inspections from a growing multitude of regulatory authorities from around the globe, a senior pharmaceutical industry executive discusses how her company has been handling this complex and challenging task.

Un-blinding, Pharmacovigilance Issues Among Top GCP Findings, Says UK Inspector

A UK good clinical practice inspector discusses common findings issued in relation to clinical trials as well as the challenges posed by new technologies, such as use of apps on smartphones and electronic patient diaries to record outcomes.

Related Content





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