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

How The European Medicines Agency Inspected Thermo Fisher’s Florida Plant Without Leaving Europe

Executive Summary

Contract development and manufacturing organization relied on combination of immersive mixed-reality devices to host remote inspection.

You may also be interested in...



ICMRA Review Finds Remote Alternatives Could Complement Onsite Inspections, Not Replace Them

Stance echoes US FDA’s view that remote alternatives should be “supplemental tools” to support in-person inspections.

World’s Pharmaceutical Inspectorates Prepare For Post-Pandemic Remote Site Assessments

US, EU, global authorities share experiences, insights, advice for industry on remote alternatives even after inspectors can resume travels.

Preparing For The Return Of US FDA Inspections

Compared to FY2019, FDA data show agency inspections of OTC and Rx drug manufacturing facilities in FY2020 fell 60%. As pandemic continues in FY2021, inspection rate will remain depressed, and it remains unclear how the agency will reduce the backlog without resorting to remotely conducted inspections.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS142580

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