Panacea Technical Articles

Working as a QPPV at Panacea
18.10.2021 | Article

Michelle Patton discusses her experiences of being an EU QPPV at Panacea.

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Developmental Risk Management Plans in Pharmacovigilance
11.10.2021 | Article

Martika Taylor, a Senior Safety Scientist at Panacea, looks at the use of Developmental Risk Management Plans (DRMPs) in Pharmacovigilance.

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Biological & Biosimilar Medicines – Pharmacovigilance Particularities from a Safety Physician’s Perspective in the EU (Part Two)
04.10.2021 | Article

Part Two looks at PV specifics and also Quality, Non-clinical and Clinical issues and their interconnection with safety.

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Biological & Biosimilar Medicines – Pharmacovigilance Particularities from a Safety Physician’s Perspective in the EU (Part One)
27.09.2021 | Article

Ludmila Curi, a Panacea EU QPPV and Safety Physician, looks at the PV considerations for Biological and Biosimilar medicines in the EU.

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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.

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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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