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 for the safety of the human pharmaceutical products marketed by that company in the EU.

2024年5月30日 · The QPPV is responsible for all aspects of PV for the products with Marketing Authorisation (MA) within the European Economic Area (EEA) and Northern Ireland and needs to reside in the EU/EEA.

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 in the Union where the QPPV operates. The QPPV has to both reside and operate in the Union.

Qualified Person for PharmacoVigilance (QPPV) Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market.

2023年10月4日 · Discover how QPPV and LPPV roles safeguard patient safety in pharmacovigilance. Learn their vital contributions to pharmaceutical industry.

• Anyone marketing a medicinal product in any of the 27 Member States of the European Union (EU) or the 3 EEA Member States (Iceland, Liechtenstein and Norway) must have a QPPV. • Also anyone applying to market a product in the above countries must prove they have the services of a QPPV in their MAA.

A Qualified Person for Pharmacovigilance (QPPV) is a regulatory requirement in the European Union (EU) for pharmaceutical companies involved in the marketing and distribution of medicinal products.

In this comprehensive guide, we provide an overview of pharmacovigilance requirements and the roles of QPPV, LQPPV, and LCPPV across all countries from. This resource will help pharmaceutical organizations and professionals navigate global regulatory frameworks, ensuring adherence to country-specific pharmacovigilance guidelines.

The appointment of a European Union (EU) Qualified Person for Pharmacovigilance (QPPV) is a mandatory requirement for all medicinal products authorised within the EU and they are responsible for ensuring that the Marketing Authorisation Holder’s pharmacovigilance system is compliant with EU requirements. Outsourcing the QPPV function can ...

2024年11月28日 · Who is a Qualified Person for Pharmacovigilance (QPPV)? A QPPV is someone with the training, knowledge and skills to ensure the safety of pharmaceutical products throughout their lifecycle. This role is legally mandatory in many …