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

EMA To Beef Up Guidance On Additional Risk Minimization Tools

Executive Summary

Based on its experience of reviewing tools used by companies for additional risk minimization, the European Medicines Agency is planning to update its guidance on this topic with more information on how these tools can be better employed.

You may also be interested in...



EMA’s Revised Guide On Additional Risk Minimization ‘Overly Detailed’

Executive Summary: The European pharma industry federation believes the advice provided in the updated draft EU guideline on additional risk minimization measures is far too detailed, resulting in a lack of focus, information overlap and confusion.

New Big Data Curriculum On The Cards For EU Regulators

The European Medicines Agency is inviting feedback from organizations interested in delivering a training program to the members of the European medicines regulatory network to improve their big data analysis and assessment skills.

New UK System Will Check Trial Sponsors Report Study Results

The UK has started monitoring whether clinical trial sponsors are fulfilling responsibilities to make their research open and transparent.

Topics

UsernamePublicRestriction

Register

PS143118

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