MHRA Inspectorate

Search results for operational transformation

Operational Transformation Programme – an Inspectorate view

Posted by: Michelle Yeomans, Posted on: 22 March 2018 - Categories: Inside the Inspectorate, Wider MHRA

You may have already heard about the MHRA Operational Transformation Programme (OTP) through taking part in a customer survey, attended MHRA symposia, participated in a stakeholder meeting or engagement workshop...

EU-FDA mutual recognition of inspections of medicines manufacturers enters operational phase

Today, 1st November 2017, the EU-FDA mutual recognition agreement (MRA) of GMP inspections of human manufacturers will start coming into force. The initial phase of the agreement starts...

It pays to be compliant!

Posted by: Michelle Yeomans, Posted on: 11 January 2019 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

Well it’s been nearly 9 months since my blog post introducing the Agency’s Operational Transformation project, and so it seemed a good time to provide an update as the first...

The 2018 Good Distribution Practice (GDP) Symposium

Posted by: Bernadette Wilson, Posted on: 11 June 2019 - Categories: Compliance matters, Events and symposia, Good distribution practice

...on our Operational Transformation programme. Richard also covered the changes to the Inspections, Enforcement and Standards (IE&S) divisional structure. Since the last symposium, the Process Licensing team has been brought...

GMDP Symposium 2017- GMP Days

Posted by: grahamcarroll, Posted on: 5 February 2018 - Categories: Compliance matters, Events and symposia, Good manufacturing practice

...activities. This included updates on the planned move of our headquarters from Buckingham Palace Road to Canary Wharf, the Operational Transformation programme and Brexit. As anticipated, we received several questions...

GMDP Symposium 2017 - GDP Days

Posted by: Bernadette Wilson, Posted on: 19 February 2018 - Categories: Compliance matters, Events and symposia, Good distribution practice

...planned move of our headquarters from Buckingham Palace Road to Canary Wharf, the Operational Transformation programme and Brexit. As anticipated, we received several questions throughout the event about Brexit; all...

The 2018 GMP Symposium

Posted by: grahamcarroll, Posted on: 4 June 2019 - Categories: Compliance matters, Events and symposia, Good manufacturing practice

...These included the successful completion of our move from Victoria to Canary Wharf and the latest news on our Operational Transformation programme. Richard also provided updates on changes within the...

Risk Adaption in Clinical Trials of Investigational Medicinal Products (CTIMPs)

Posted by: Kath Meely, Posted on: 16 November 2017 - Categories: Compliance matters, Good clinical practice

...of difference of the trial-related intervention from normal clinical practice, the complexity of the protocol, and the specific operational aspects of the planned clinical trial or the clinical development project....

Process Licensing Office joins the Inspectorate

Posted by: Mark Birse, Posted on: 1 August 2018 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate

...Freedom of Information (FoI) requests on behalf of IE&S. This change forms part of the ongoing Transformation programme at MHRA and is effective from 1st August 2018. The new team...

Welcome to the MHRA Inspectorate blog

Posted by: Mark Birse, Posted on: 23 June 2015 - Categories: Compliance matters, Inside the Inspectorate

...for the Inspectorate here at MHRA. I joined the agency in 2002 after working for 10 years in the pharmaceutical industry. I’m responsible for 4 groups covering our operational activities,...