Panacea Technical Articles

The Transition from Nursing to Pharmacovigilance
23.07.2021 | Article

Panacea’s Michaela Muller talks about her experiences moving from nursing to a career in pharmacovigilance.

Read More
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.

Read More
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.

Read More
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.

Read More
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.

Read More
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).

Read More
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.

Read More
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.

Read More