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

UsernamePublicRestriction
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.

EU Politicians Squeeze Pharma Execs On Coronavirus Vaccine Contracts

With coronavirus cases again on the rise in many European countries, members of two EU parliamentary committees asked industry representatives to explain why details of COVID-19 vaccine supply agreements are being kept under wraps.

Topics

UsernamePublicRestriction

Register

SC081785

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