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Pharmacovigilance - an introduction

The course is applicable for new employees within the area. Learn about pharmacovigilance for products for human use, the current requirements in EU and Denmark, and how they are handled by the industry, by the authorities and EMA.


Pharmacists, doctors, pharmaconomists, hospital nurses, and others working with adverse events surveillance and reporting. The course is an introduction to pharmacovigilance and is applicable for new employees within the area.


To give participants a basic introduction to the current requirements in order to highlight responsibilities applicable both for the marketing authorisation holder and the sponsor for clinical trials. To give participants a basic introduction, to the most important terms and the practical handling of Pharmacovigilance for medicinal products for human use. To create an option for dialog between the authorities and the industry.


Medicinal products become more and more potent, why further requirements are needed regarding careful surveillance of the risks to the use of the products.
The legislation is affected by this, and over the years more requirements to the reporters and the marketing authorisation holders have been implemented.
Today there are specific requirements for

  • hat to report,
  • who must report, and
  • when to report, and also
  • how to report, and
  • whom to report to

The course include the following topics: Current requirements and how they are implemented, including the role of the QPPV and a short introduction to the Pharmacovigilance System Master File (PSMF). Handling of cases from real life, short description of data used for Periodic Safety Update Reports (PSUR), Risk Management Plans (RMP), Signal detection and Development Safety Update Report (DSUR).

Course language: English
The tutors are Danish i.e. questions can be asked both in Danish and in English.

Principal Drug Safety Adviser Jette H. Lindgren, Alk-Abello A/S.

Inge Fabech, if@pharmakon.dk, 4820 6120

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