Welcome to the event hub for the MHRA Good Practice Symposia in February 2020. There will be 3 consecutive events commencing Tuesday 11 February 2020.
MHRA Good Pharmacovigilance Practice Symposium (GPvP) - Tuesday 11 February
The 2020 GPvP Symposium will provide an insight into the key topics and compliance trends in pharmacovigilance observed by the MHRA GPvP inspectors since the 2018 Symposium. The event is relevant to anyone working in pharmacovigilance, medical information and regulatory affairs, including EU QPPVs and service providers.
MHRA Laboratories Symposium (Labs) - Wednesday 12 February
This years Laboratories event will highlight the importance of 'fit for intended use' in the context of regulated work across GLP, GCP and GMPQC Laboratories. The content of the event is intended to illustrate that this topic is not just limited to facilities and equipment but can be applied across an organisation, from people and training to quality management systems and report production. The day will include presentations from Laboratory inspectors, example findings and expectations relating to laboratory practice, an opportunity to meet with Inspectors to ask questions and interactive sessions to get the audience involved. After the event, delegates will have a better understanding of the Laboratory inspectors position on the topic of ‘fit for intended use’ and how this can be applied in day to day regulated work.
Good Clinical Practice (GCP) Symposium (Commercial) - Thursday 13 - Friday 14 February
This Symposium is in partnership with the US Food and Drug Administration (FDA).
Following on from the Good Clinical Practice for non-commercial organisations which took place on Wednesday 11 September 2019, this symposium is primarily focused at commercial organisations.
Regulatory agencies conduct Good Clinical Practice (GCP) inspections to assure the integrity of data generated in clinical trials and to confirm the protection of human research subjects, in addition to ensuring that clinical trials are conducted according to the applicable regulations. With the globalisation of clinical trials, regulators have increased collaboration amongst themselves to evaluate the adequacy of clinical trial conduct to optimise regulatory resources and oversight.