Pharmacovigilance - an introduction

What you need to know.

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).

The participants 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. Using interactive learning, the participants will be able to explain the purpose and objectives of pharmacovigilance, state important elements of a pharmacovigilance system and demonstrate their connections and interactions to each other.

 

In this course you will be introduced to:

Senior Database Manager, Diploma in Pharmacovigilance Jette H. Lindgren, ALK-Abello A/S

Deputy EU-QPPV & Drug Safety Adviser Klaus Bitsch-Jensen, ALK-Abello A/S

Kursusfakta
Niveau
Specialiserede
Format
Flerdageskursus
Vurdering
4,7 ud af 5
Pris
9.500 kr. ekskl. moms, overnatning ikke inkluderet
Tilmeld dig her
Pharmakon Konferencecenter, Hillerød
18. mar.
09:00 - 16:00
19. mar.
09:00 - 16:00
2020
Pharmakon Konferencecenter, Hillerød
06. okt.
09:00 - 16:00
07. okt.
09:00 - 16:00
2020

Dine fordele ved at vælge dette kursus

Dit udbytte

  • Basic introduction to the current legal requirements.
  • Fundamental knowledge of practical handling of pharmacovigilance.
  • Knowledge of responsibilities of the marketing authorisation holder and the sponsor.

Din virksomheds udbytte

  • Share knowledge of the current legal requirements.
  • Possess knowledge of responsibilities of the marketing authorisation holder and the sponsor.
  • Ensure compliance within Pharmacovigilance requirements.
02_social-samvaer
SOCIALT SAMVÆR I LÆKRE LOUNGEOMRÅDER
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UNDERVISER MED PÆDAGOGISKE KOMPETENCER
09_laekker-forplejning
LÆKKER FORPLEJNING
Alles engagemant 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 udlevet på forhånd. Godt så noter kunne noteres her.
EVALUERING AF KURSET 2019

Målgruppe

Healthcare professionals and others who have either just started working within pharmacovigilance or as part of their role is having an interfaces with pharmacovigilance.

Kursusagenda

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 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 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.

 

Course language: English

Tilmeld dig her
Pharmakon Konferencecenter, Hillerød
18. mar.
09:00 - 16:00
19. mar.
09:00 - 16:00
2020
Pharmakon Konferencecenter, Hillerød
06. okt.
09:00 - 16:00
07. okt.
09:00 - 16:00
2020