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.
Good clinical practice
Sponsor Oversight- Part 2
Part two of this post provides two case studies from inspections where critical and major findings have been identified in regards to Organisation’s Oversight of Clinical Trials of IMP.
National and International GCP Symposia
Posted by:
Paula Walker, Posted on:
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Categories:
Compliance matters, Events and symposia, Good clinical practice
On the 5 and 6 September, the GCP Inspectorate held their symposium and were joined by colleagues from the FDA, the Brazilian authority ANVISA and the Israeli Ministry of Health.
Process Licensing Office joins the Inspectorate
Posted by:
Mark Birse, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate
The Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group.
Sponsor Oversight- Part 1
The first of two posts focusing on sponsor oversight and how to improve compliance in this area.
GCP Symposium 2018
Posted by:
Mandy Budwal-Jagait, Posted on:
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Categories:
Compliance matters, Events and symposia, Good clinical practice
Find out how to register for the 2018 GCP Symposium.
PIC/S press release following April 2018 meeting
Posted by:
Mark Birse, Posted on:
-
Categories:
Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate
From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
MHRA’s GXP data integrity guide published
Posted by:
Tracy Moore, Posted on:
-
Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice
The MHRA’s GXP data integrity guide has been published today.
Looking for a New Challenge in 2018?
Posted by:
Mark Birse, Posted on:
-
Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate, Wider MHRA
Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator.
Risk Adaption in Clinical Trials of Investigational Medicinal Products (CTIMPs)
MHRA are actively promoting a risk proportionate approach to CTIMPs
Related content and links
