qppv

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Pharmacovigilance

Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) – An Overview

A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...

Pharmacovigilance

An Overview of the PSMF: Pharmacovigilance System Master File

What is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...

Pharmacovigilance

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

Introduction According to §63a of the German Medicinal Products Act (AMG), a pharmaceutical entrepreneur who places finished medicinal products on the market that are medicinal products within the...

Pharmacovigilance

The LPPV Network: An Essential Guide to Local Person Responsible for Pharmacovigilance

Every marketing authorization holder (MAH) needs a pharmacovigilance system to guarantee the safety of its products. Within the EU a pharmacovigilance system is defined as a system used by an...

Pharmacovigilance

The QPPV: An Essential Guide to the Qualified Person Responsible for Pharmacovigilance

When submitting marketing authorisation applications (MAAs) in Europe, the applicant (Marketing Authorization Holder, MAH) shall already have set up a pharmacovigilance system. A Summary of the...

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Pharmacovigilance

Achieving Success with Regulatory Intelligence in Pharmacovigilance

What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...