Pharmacovigilance - an introduction

Pharmacovigilance - an introduction

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

What do you get from this course?

What you get

• You know the current legal requirements and guidelines for Pharmacovigilance
• You have a fundamental knowledge of the practical handling of Pharmacovigilance
• You are aware of the responsibility of the marketing authorisation holder and the sponsor

What your organization gets

• Your employee can assess whether your systems are compliant and ready for Pharmacovigilance
• Your employee will handle pharmacovigilance timely and in a correct manner
• Your employee possesses knowledge of the responsibilities of the marketing authorisation holder and the sponsor

Agenda

You will be introduced to core elements within a pharmacovigilance system and its quality system and how these elements are described and documented in the Pharmacovigilance System Master File (PSMF).

You will learn how adverse events received from spontaneous sources, clinical trial sources and other solicited sources are to be handled. This includes, among other things, the assessment, evaluation and reporting to competent authorities of Individual Case Safety Reports (ICSRs), 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.

The course will be taught in english.