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eConsent
eConsent
A joint MHRA/HRA statement has been published which sets out the legal and ethical requirements for seeking and documenting consent using electronic methods.
I don't believe it!
Guidance and examples of data integrity issues seen on GDP inspections.
The GDP Inspectorate team are hiring
The GDP Inspectorate are currently recruiting, find out more about the role and how to apply.
PIC/S press release following April 2018 meeting
From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
Obtaining medicines for wholesale using prescriptions and an important update on attempted thefts from warehouses
The GDP inspectorate has seen a growing number of false NHS and private prescriptions being used to obtain medicines from Marketing Authorisation Holders for the onward wholesale.
VHP (Vapour Hydrogen Peroxide) Fragility
This post provides guidance around the use of VHP for sterilization purposes
Guidance around the urgent supply of unlicensed medicines imported out-of-hours by UK hospitals.
This post provides guidance around the urgent supply of unlicensed medicines that have needed to be imported out of hours by UK hospitals.
Operational Transformation Programme – an Inspectorate view
This post provides some background information to the aims of the operational transformation programme and how the inspectorate is rising to the challenge.
MHRA’s GXP data integrity guide published
The MHRA’s GXP data integrity guide has been published today.
Out of Specification Guidance
The issue faced when dealing with out of specification (OOS) results is as much a challenge now as it ever was. This post provides some guidance on how to handle OOS results.
MHRA Pharmacovigilance Symposium 2018
Find out here how to register for the 2018 pharmacovigilence symposium which will include topics such as inspection findings and trends, a talk on service providers and outsourcing and areas of change such as signal detection in Eudravigilance.