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

New French Clinical Trial Rules Focus on Phase I

Executive Summary

New clinical trial rules have been introduced in France covering aspects such as safety reporting for volunteer trials, trial site authorization, and a clearer distinction of trial type in terms of risk level.

You may also be interested in...



Better Risk Assessment And Dose Determination Key To EMA's Plans For Updated Phase I Trial Guideline

Proposed revisions to the European Medicines Agency's guideline on first-in-human studies are intended to help identify and reduce the risks to study participants by making better use of non-clinical data in areas like the choice of the therapeutic dose, the dose escalation strategy, and the criteria for stopping a trial.

Companies Dive Into French Stress Test Of Future EU Trial Procedures

The French regulator ANSM says that pharmaceutical companies and ethics committees have shown keen interest in its pilot project intended to test how the clinical trial application process will work under the EU's Clinical Trials Regulation, with 11% of all trial applications being filed within the framework during its first six months1.

Post-Brexit UK Risks Being ‘Left Out In The Cold’ As EU Coordinates Action On Shortages

The UK is not alone in experiencing drug shortages, as data from across Europe show, but its departure from the EU makes it more difficult to respond to supply chain pressures, according to new research.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS119585

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