Pharmacovigilance - an introduction

Today’s requirements and awareness of safety on medicinal products is an important task at any life science company; a solid and robust pharmacovigilance system with effective and efficient procedures and processes are needed, to ensure that the benefits of the medicinal product exceed the risks by the greatest achievable margin.

You will be introduced to core elements within the pharmacovigilance system and its quality system and how these elements are described and documented in the Pharmacovigilance System Master File. You will learn how adverse events received from spontaneous sources, clinical trial sources and other solicited sources are handled. This includes, among other things, the assessment, evaluation and reporting to competent authorities of Individual Case Safety Reports, signal detection and management, safety risk management and benefit-risk evaluation of a medicinal product.

The role and responsibilities of the marketing authorisation holder towards the pharmacovigilance system and the Qualified Person responsible for Pharmacovigilance (QPPV) will also be covered as well as how audits and inspections of the pharmacovigilance system are conducted.  

You will be able to explain the purpose and objectives of pharmacovigilance, state important elements of a pharmacovigilance system and demonstrate their connections and interactions.

The course consists of presentations from experts, discussions based on your own experiences and group work.

The course language is English.

At the course you will meet:
Jette H. Lindgren, Senior Database Manager, ALK-Abello A/S
Klaus Bitsch-Jensen, Deputy EU-QPPV, Head of QPPV Office, ALK-Abello A/S
Tina Maria Greve, Senior Drug Safety Advisor, ALK-Abello A/S
Fida Issa, Safety Surveillance Specialist, Novo Nordisk A/S