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

ICH Q12 to Foster Post-Approval Change Management

This article was originally published in The Gold Sheet

Executive Summary

Expert working group forming to develop Q12 guideline to explore “regulatory commitments” concept and proactive post-approval change management plans. But there will be challenges and the devil, as always, will be in the details.

You may also be interested in...



ICH Seeks To Resolve Impasse Over Q12 Legal Review This Week

It remains uncertain whether a legal review by the European Commission that since June has delayed public consultation of draft ICH Q12 post-approval changes guideline can be resolved during this week's ICH meeting in Geneva.

ICH Q12 Experts Develop Four-Tier Scheme For Harmonizing Post-Approval Changes

Ambitious effort to enable fuller, quicker rollout of post-approval manufacturing changes progressed at ICH meeting in Lisbon, participants told recent conferences. Much of the focus of ICH Q12 discussion was on harmonized reporting categories so manufacturers could make more changes before obtaining approval – and in some cases without even seeking approval.

A Pandemic Template For Swift Approval? Veklury Stability Questions Deferred For Later Study

The US FDA shaved months from review of Gilead’s Veklury (remdesivir) for COVID-19 with post-approval commitments for multiple stability studies. The Pink Sheet takes a deep dive look at discussions within the agency and with the sponsor.

Topics

UsernamePublicRestriction

Register

OM007016

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