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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....

Post-transition: Pharmacovigilance requirements for UK authorised products - Thursday 22 October 2020

https://youtu.be/I3CkPHWQI8M Post-transition: Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 22 October 2020]}**. This webinar was part of a series of EU Exit and post-transition guidance...

MHRA planning for return to on-site Good Practice (GxP) inspections

Virus Particles

On 23rd March 2020]}** I published a post outlining changes to MHRA’s GxP inspection programme during the COVID19 outbreak. This enabled industry and the NHS to focus on medicine supply...

Guidance on pharmacovigilance requirements for UK authorised products from 1 January 2021

Posted by: , Posted on: - Categories: Compliance matters, Good pharmacovigilance practice

Since before the end of the transition period on 31 December 2020]}**, we have been working hard to provide the guidance you need to become familiar with the pharmacovigilance requirements...

MHRA data integrity guidance: 18 months on

MHRA has produced draft GxP data integrity guidance for industry and we welcome your comments”

...been encouraging to see industry stakeholders and regulatory partners adopting a common approach in their own publications and the messages and themes being echoed in online discussions, workshops and conference...

What does qualification of suppliers mean to you? Risks to patients and to your business

A pair of spectacles in front of a computer screen representing careful scrutiny of data

...15mg, 30mg or 60mg. For Tramadol, just Tramadol Hydrochloride, tablets or capsules. No return is required for any mixed API products. A big thank you to the companies providing this...

Joining and working for the Inspectorate

Reaching for the sky

...was the start of my journey. The application process is designed to not only challenge your experience and knowledge, but also to look at your personality profile. After several online...