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Global reflections on international inspection transformation: ICMRA remote inspections

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good manufacturing practice

In August 2020 the International Coalition of Medicines Regulatory Authorities (ICMRA) established a working group to look at the move to remote inspections for GCP and GMP during the pandemic....

Virtual conference: The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) Revision

Posted by: , Posted on: - Categories: Compliance matters, Events and symposia, Good clinical practice

...Trials Transformation Initiative (CTTI; a public-private partnership co-founded by the US Food and Drug Administration and Duke University in 2007). The EWG is holding 2 similar meetings on Tuesday 18...

Inspectors grounded - a year of innovation

...or being able to ‘dig around’ to see what the compliance level of a facility is really like. As Chair of the ICMRA Covid-19 working group on the Digital Transformation...