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

Straightforward But Technical: Transferring Existing Studies To EU Clinical Trial Portal

Executive Summary

At a webinar organized by the European Medicines Agency, EU member states discussed their experiences with reviewing the requests made by trial sponsors to switch existing studies to the Clinical Trial Regulation.

You may also be interested in...



Not A Smooth Ride: How One Of The First Studies Navigated The EU Clinical Trial Portal

 From grappling with a never-ending list of conflicting national requirements to dealing with numerous technical issues, a research project manager at Norway’s Oslo University Hospital talks about the hiccups faced by their multinational COVID-19 platform trial that was among the first studies submitted for approval under the EU Clinical Trial Regulation.

Here At Last: A New Era For Clinical Trials In The EU

A long-awaited regulation introduces major changes in the way that clinical trials are conducted across the EU, including a single application portal and new trial transparency requirements.

EMA To Update Active Substances Guide To Address Nitrosamine Contamination

The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS146769

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