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

Yet Another Delay For Landmark EU Clinical Trial Rules – Now To 2019

Executive Summary

The go-live date for the coming EU Clinical Trial Regulation and accompanying portal and database is being postponed again. The delay will also impact the EMA’s schedule for training drug sponsors and European authorities in how to use the portal and database.

You may also be interested in...



Pharma Requests Pilot To Test Public Value Of EU Guide On Plain Language Summaries

The European pharmaceutical trade group EFPIA says an “initial pilot” program should be launched to test the value and impact of the draft EU guideline on presenting lay summaries of clinical trial results. The group believes that the guideline should be reviewed following the pilot, as complying with it in its current form would result in companies shelling out “significant additional resources.”

Pharma Calls For Practical Advice On Using Risk-Based Approach To Trials in EU

The pharmaceutical industry and other stakeholders are calling for practical advice on how the new EU guideline on using a risk-proportionate approach to clinical trials will be implemented in practice. Clarity has been sought on several topics, especially on new requirements such as preparing a risk assessment and mitigation plan as part of a trial protocol.

Training For ‘Huge’ EU Clinical Trials Portal And Database On Track For 2017

“Thousands and thousands of people” will be using the EU clinical trials portal and database after it goes live late next year and the European Medicines Agency plans to “invest a lot” this year in teaching trial sponsors and EU member state authorities how to use the new system. The EMA is also still working on ironing out the tricky areas of user management and how to transition legacy trials.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS120892

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