Panacea Technical Articles

Successful Pharmacovigilance Outsourcing
10.03.2021 | Article

An alternative to the traditional in-house PV model is the outsourcing of PV work to a specialist company. Outsourcing is a solution that allows the delegation of the PV responsibilities to specialist service providers.

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GVP Audits – What should I expect and how can I best prepare?
03.08.2020 | Article

Due to the high number of audits required, it is essential that Marketing Authorisation Holders (MAH) and their service providers are well prepared.

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Is Globally Harmonised Pharmacovigilance Possible; What Are the Challenges?
02.06.2020 | Article

Global harmonisation of PV is a work in progress, something we all need to pay attention to, whether we are a leading think tank or a small PV service provider.

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Pharmacovigilance Agreements (PVA's) – Five key aspects that should be included
21.06.2018 | Article

A PVA is a written agreement between the MAH and a third party which outlines the responsibilities of each party with regards to pharmacovigilance.

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EVDAS and the new Pharmacovigilance Signal Management Requirements
09.04.2018 | Article

The EudraVigilance database is an important source of signals. MAH's can access the database via the EudraVigilance Data Analysis System (EVDAS).

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The Benefit : Risk Balance - Proactive Pharmacovigilance
16.02.2018 | Article

Benefit: risk assessment is an important term in pharmacovigilance, it is something that all pharmacovigilance professionals should be thinking about on a daily basis.

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The Pharmacovigilance Risk Management Plan
10.01.2018 | Article

A Risk Management Plan (RMP) was first introduced into pharmacovigilance in 2005. In 2012, along with the new legislation, a new format of the RMP was introduced, as well as GVP Module V.

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