A link to the newly published ICMRA paper, which provides a valuable insight into how global regulators have managed regulatory oversight, inspections and assessments during the pandemic to support both the COVID-19 response, and also ‘business as usual’ GMP and GCP inspections.
GCP inspections and how they are conducted has evolved over the years due to the increased complexity of trials, organisations, implementation of electronic clinical trial systems and the development of technology.
In the modern world it is increasingly common to see flexible, part-time or home working arrangements. The pharmaceutical industry is no exception, and with some companies employing a part-time or contract Qualified Person (QP), it is no surprise that the QP continues to play a key role even when away from the site.
The MHRA GMDP Symposium took place on 11 to 14 November 2019 in London and 26 to 27 November 2019 in Glasgow. The theme of the GMP event was ‘Control Strategies’, whilst the GDP days focussed on supply chain challenges faced by wholesalers.
In part 1 of the inspectorate recruitment posts, we provided information on the inspector role and recruitment process, part 2 provides more information on the benefits and opportunities available to MHRA inspectors.
Have you ever thought about becoming an MHRA inspector but wanted to know more about the role, the application process, or the benefits associated with joining a talented and dynamic team protecting public health? Part one of this two-part blog will hopefully give you the information you need to consider for applying for future roles.
Between 11 to 14 February 2020, the MHRA will be hosting a week-long series of events as part of the Good Practice Symposia Week. The week will include individual events from GPvP, GCP and GLP Inspectorates
The annual GCP Symposium was held by the MHRA on 11 September 2019 in Manchester. The symposium focused on non-commercial organisations (Trusts/Health Boards/University sponsors, Charities and investigator sites) and covered a variety of topics.
A principle objective of both the MHRA and of pharmaceutical companies is to protect and improve the health of patients. When new information about the benefits and risks of a medicine become available it is often appropriate to make changes to the safety information for the product.
The GXP environment is evolving as digital technologies are increasingly being applied to the development and manufacture of medicines.
On Tuesday 7 May 2019 representatives from trade organisations, professional bodies, non-commercial organisations and other regulators and government functions involved in the analysis of clinical trial laboratory samples were invited to attend the inaugural GCP Laboratories Stakeholder Engagement Meeting (StEM) …
