Panacea’s Michaela Muller talks about her experiences moving from nursing to a career in pharmacovigilance.
Read MoreAn 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 MoreDue to the high number of audits required, it is essential that Marketing Authorisation Holders (MAH) and their service providers are well prepared.
Read MoreGlobal 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 MoreA PVA is a written agreement between the MAH and a third party which outlines the responsibilities of each party with regards to pharmacovigilance.
Read MoreThe EudraVigilance database is an important source of signals. MAH's can access the database via the EudraVigilance Data Analysis System (EVDAS).
Read MoreBenefit: risk assessment is an important term in pharmacovigilance, it is something that all pharmacovigilance professionals should be thinking about on a daily basis.
Read MoreA 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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