UK MHRA Pilot To Explore Benefits Of Standalone Inspections For Pharmacovigilance Service Providers
This article was originally published in SRA
Executive Summary
The UK Medicines and Healthcare Products Regulatory Agency has launched a pilot to ascertain whether the introduction of a new standalone program, under which it would inspect pharmacovigilance service providers, could cut inspection costs incurred by drug companies that use these third-party organizations and also save agency resources.
You may also be interested in...
UK MHRA Adapts Inspections Program To Account For Increase In Pharmacovigilance Outsourcing
As drug companies increasingly outsource their pharmacovigilance activities to third party organizations, the UK regulator has made changes to its inspections program so that all affected marketing authorization holders are kept abreast of any problems identified at contract service providers.
EU Regulators Explain How To Ensure Transitioned Trials Align With CTR
Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.
Global Medtech Guidance Tracker: March 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-nine documents have been posted on the tracker since its last update.