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

European Inspectors Spot GMP Deficiencies In India During ‘Virtual Tours’

It Almost Felt Like We Were There, Says EDQM Inspector

Executive Summary

A senior inspector at the European Directorate for the Quality of Medicines & HealthCare explained how some “out-of-the-box thinking” was leading to a new approach for inspecting companies. 

You may also be interested in...



Dr Reddy's On Digitization Amid COVID-19, 'Lights-Out' Manufacturing

Dr Reddy’s global head of quality outlines how the company leveraged digitization to keep plants running at full throttle amid the pandemic and went on to operationalize a site for remdesivir designed as a "lights out" facility. Certain facilities at the Indian firm have also undergone remote inspections by major regulatory agencies.

ICH Consults On Modernized GCP Principles To Make Clinical Trials More Efficient

The International Council for Harmonisation has issued updated Good Clinical Practice principles to accommodate new clinical trial and data types.

EMA Looks For Efficiencies For Companies Ahead Of Relaunching Clinical Data Transparency Policy

Based on its learnings from proactively publishing clinical trial data on COVID-19 products, the European Medicines Agency is making procedural changes to its clinical data publication policy that is set to resume after being temporarily suspended in 2018.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS143703

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