INTRODUCTION TO MEDICADEMY PHARMACOVIGILANCE
Pharmacovigilance is the science related to detection, assessment, understanding and prevention of adverse effects of medicines. Pharmacovigilance evaluates information from pharmaceutical companies, healthcare professionals, and patients with a view to finding new data about hazards associated with medicines and preventing harm to patients, and is truly a science in the ’Service of Safety’.
To meet the general and increasing demand for pharmacovigilance professionals, the Danish Association of the Pharmaceutical Industry (Lif), the Faculty of Pharmaceutical Sciences, University of Copenhagen (PHARMA, KU), and the Danish Medicines Agency (DMA) established an international training programme in pharmacovigilance in 2008.
Medicademy Pharmacovigilance consists of eight modules, each of 2-4 days duration, and is a flexible part-time postgraduate programme with special emphasis on understanding pharmacovigilance issues based on a practical industry approach.
Module 1: Principles of Pharmacovigilance
Module 2: Pharmacovigilance Systems – A Hands-on Approach
Module 3: Pharmacoepidemiology
Module 4: Post-Marketing Surveillance
Module 5: Pre-Clinical and Clinical Aspects of Pharmacovigilance
Module 6: Pharmacovigilance Data in Application and Registration
Module 7: Adverse Drug Reactions by Body Systems
Module 8: Veterinary Pharmacovigilance
THE EIGHT MODULES COVER KEY STAGES OF A DRUG’S LIFECYCLE AND AIM TO SATISFY THE EDUCATIONAL NEEDS OF PRACTICING PHARMACOVIGILANCE PROFESSIONALS.
The Medicademy Pharmacovigilance programme may result in:
- Diploma in Pharmacovigilance or
- Individual training process
Medicademy allows students to attend the modules in random order and in that way design their own diploma. Students must, however, pass five modules in order to be awarded the Diploma in Pharmacovigilance. One module from the Medicademy Regulatory Affairs programme may be included in the Medicademy Pharmacovigilance Diploma, however, four of the five modules must be chosen among the modules 1-7.
Medicademy Pharmacovigilance aims to provide the students with an in-depth and up-to-date knowledge of the most important theoretical and practical aspects of pharmacovigilance. The seven modules primarily focus on the European environment, but reference is also made to the USA, Japan, and other relevant countries and regions.
The modules in Medicademy Pharmacovigilance are targeted at pharmacovigilance professionals, who wish to further develop their experience and knowledge by either obtaining a Diploma or by attending individual modules of own choice. The modules are primarily designed for professionals with a relevant Bachelor Degree or similar qualifications or relevant experience from the pharmaceutical/biotech industry.
Medicademy Pharmacovigilance has been developed by a team of internationally experienced pharmacovigilance experts, including experts from the pharmaceutical/biotech industry, the Danish Medicines Agency, the Swedish Medicines Agency, and researchers from the Faculty of Pharmaceutical Sciences at the University of Copenhagen and the University of Southern Denmark. Through their representation in the Steering Committee and as frequent course leaders and lecturers in the individual modules, all these experts are involved in the continuous development of the programme.
The faculty employs lecturers from the pharmaceutical industry, health authorities, and universities. The actual learning activities include class teaching, self-studies, interactive discussions, and case studies and each module is concluded with an examination approximately 4 weeks after the module.
Information regarding the Diploma, individual modules, entry requirements, examinations, applications, payment, etc. will be specified on the following pages.
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Phone: +45 39 15 09 10
Fax: +45 39 27 60 70