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Nov 04, 2021

Regulatory Affairs Outsourcing: Benefits, Tasks and Future Perspectives

The pharmaceutical market is rapidly evolving and changing. Many pharmaceutical companies are…

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Oct 18, 2021

QPPV Outsourcing in EU/EEA and its benefits for MAH

To place its medicines on the market in the European Union (EU)…

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Jul 21, 2021

Integration of Pharmacovigilance Systems Under a Mutual Operating Guide

Pharmacovigilance (PV) activities are fundamental to both patient safety and regulatory compliance,…

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May 05, 2021

Local Safety Responsible (LSR): Where it Stands Among Other Roles of Pharmacovigilance Specialists

As part of a pharmacovigilance (PV) system, Marketing Authorization Holders (MAHs) must…

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Apr 26, 2021

Safety Management Plan and its Importance in Clinical Trials

The Safety Management Plan (SMP) is one of the most important documents…

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Dec 16, 2020

BREXIT – Key Changes in the UK Pharmacovigilance System

The United Kingdom (UK) has left the European Union (EU), and the…