Pharmacovigilance services for the Pharmaceutical Industry.

Is the Local Medical Literature Search in Pharmacovigilance really an obligation?

  • January 19, 2022

It is well known that the medical literature is a significant source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products. However, we may have doubts about whether it is really mandatory or not. And indeed, yes, it is an obligation. The European Medicines Agency confirms this in the Good Pharmacovigilance Practices (GVP) Module VI: "The marketing authorisation holder should ensure that the literature review includes the use of reference databases that contain the largest reference of articles in relation to the medicinal product properties." "In addition, marketing authorisation holders should have procedures…

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PVpharm provides Local Contact Persons for Pharmacovigilance (LCPPVs) in the EU and the UK

  • January 22, 2021

PVpharm provides the Local Contact Person for Pharmacovigilance (LCPPV) in all EU countries and UK, besides we can also provide the EU Qualified Person for Pharmacovigilance (EU QPPV), UK QPPV and and Deputy persons with large knowledge and experience of the industry. Any medicinal product cannot be authorized in the EU without a Qualified Person for Pharmacovigilance (EU QPPV). The EU QPPV is responsible for the establishment and maintenance of the MAH's PV system, therefore must have adequate oversight and authority to affect the performance of the quality system and the PV activities, and to maintain and improve compliance with…

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