Pharmacovigilance - an introduction

Understand the concepts and be prepared to act

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

Today’s requirements and awareness of safety on medicinal products is an important task at any pharmaceutical company. A solid and robust pharmacovigilance system with effective and efficient procedures and processes is 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 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 (MAH) 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 own experiences and group work.

 

The course language is English.

 

You will meet:

  • Senior Database Manage, Diploma in Pharmacovigilance Jette H. Lindgren, ALK-Abelló A/S
  • Deputy EU-QPPV & Drug Safety Adviser Klaus Bitsch-Jensen, ALK-Abelló A/S  
Kursusfakta
Niveau
Specialiserede
Format
Flerdageskursus
Vurdering
4,7 ud af 5
Pris i år
9.500 kr. ekskl. moms, overnatning ikke inkluderet
Tilmeld dig her
Hillerød
6. okt.
7. okt.
2020

Dine fordele ved at vælge dette kursus

Dit udbytte

Your profits

  • 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

Din virksomheds udbytte

Your company's profits

  • 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
02_social-samvaer
SOCIALT SAMVÆR I LÆKRE LOUNGEOMRÅDER
03_underviser-paedegog-komp
UNDERVISER MED PÆDAGOGISKE KOMPETENCER
09_laekker-forplejning
LÆKKER FORPLEJNING
Alles engagement i deres emner. Dejligt med mange eksempler fra virkeligheden. God connection/rød tråd gennem de forskellige emner.
EVALUERING AF KURSET 2019
Materialet, lokale og forplejning var super godt. Rart med forskellige oplægsholdere. Gruppearbejdet skabte et godt overblik og forståelse.
EVALUERING AF KURSET 2019
Materiale var udleveret på forhånd. Godt så noter kunne noteres her.
EVALUERING AF KURSET 2019

Målgruppe

The course is aimed at healthcare professionals and others who have either just started working within pharmacovigilance or as part of their role is having interfaces with pharmacovigilance.

Kursusagenda

You will be provided with a basic introduction to the current pharmacovigilance requirements, highlighting responsibilities applicable for both the marketing authorisation holder and the sponsor for clinical trials. 

 

The course duration is one and a half day. Accommodation is not included.

 

Day 1: 9.00 - 16.15

  • Pharmacovigilance and the legislation
  • The quality system 
  • Practical experience with Pharmacovigilance and clinical trials
  • Practical experience with Pharmacovigilance Post Marketing 

Day: 9.00 - 15.15

  • EU QPPV (Qualified Person for PharmacoVigilance) and PSMF (Pharmacovigilance System Master File) 
  • Audits and inspections

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

Tilmeld dig her
Hillerød
6. okt.
7. okt.
2020