2020年12月31日 · Statutory guidance concerning the QPPV for UK authorised products is described in the Good Pharmacovigilance Practices (GVP) Module I. This guidance is …

2020年12月31日 · The QPPV for UK nationally authorised products (including both Category 1 and Category 2 products as well as PLNI licenses and PLGBs) ) can reside and operate …

2025年1月8日 · In the first instance, this correspondence will be done via the Qualified Person for Pharmacovigilance (QPPV) but a different or additional contact for future correspondence can …

2024年5月30日 · Learn about the essential role of the Qualified Person Responsible for Pharmacovigilance (QPPV) who ensures compliance and oversight in the EU/UK PV system.

On 4th September 2020, the MHRA issued preliminary guidance on the role of the Qualified Person for Pharmacovigilance (QPPV) for MAHs in the UK or Great Britain (GB), the “QPPV”. …

2009年1月7日 · The PSMF must be located either at the site in the Union where the main pharmacovigilance activities of the marketing authorisation holder are performed or at the site …

2021年2月12日 · Guidance on the UK qualified person for pharmacovigilance (QPPV) and the pharmacovigilance system master file (PSMF), as well as submission of the summary of …

2023年10月25日 · Statutory guidance concerning the QPPV for UK authorised products is described in the Good Pharmacovigilance Practices (GVP) Module I. This guidance is …

In the European Union, the Qualified Person Responsible For Pharmacovigilance (QPPV) is an individual, usually an employee of a pharmaceutical company, who is personally responsible …

Currently, there are 2 different options to remain compliant with UK law: The MA has 2 QPPVs, a UK QPPV covering the UK (including Northern Ireland) and an EU QPPV covering Northern …