GOV.UK
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.
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
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.
What to expect from GPvP inspections
The GPvP webpage has recently been updated to provide additional information about the current inspection process. This post provides some further information about GPvP inspectors and inspections.
The Responsible Person named on the WDA- Part 3: Expectations for the engagement of consultants as contract RPs
This is the final of three posts centered around the Responsible Person named on a Wholesale Distribution Authorisation (WDA) and covers the engagement of a contract RP
Process Licensing Office joins 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.
The Responsible Person named on the WDA -Part 2: Effective Appointment and Training
This is the second in a set of three posts centred around the Responsible Person named on a Wholesale Distribution Authorisation (WDA). This post has been written to enhance the appointment of the RP.
MHRA Pharmacovigilance Symposium 2018
In may, the GPvP Inspectorate held their symposium, which provided a platform for information sharing and discussion between inspectors and assessors from the MHRA and industry colleagues working within pharmacovigilance and associated departments.
The Responsible Person named on the WDA. Part 1: Raising the profile of the RP
This is the first in a set of three posts centered around the RP named on a WDA. This post provides information on external training recognition and training providers. The second of these three posts aim to enhance the appointment of the RP and the third post will place a particular emphasis on the engagement of a contract/consultant RP.