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...
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...
...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...
...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...
...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...
...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...
...normal clinical practice, the complexity of the protocol, and the specific operational aspects of the planned clinical trial or the clinical development project. The guidance covers areas where the regulation...
...the trial objectives, operationally feasible, avoid unnecessary complexity and are proportionate to protection of participants’ safety, rights and well-being and the reliability of the trial results. I suggest that this...
...at the MHRA introduced delegates to the MHRA’s RegulatoryConnect project—a far-reaching data-driven transformation of regulatory systems which will impact on how data is submitted by MAHs as well as how...
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....
