Pharmacovigilance

An international training programme

A practical industry approach

There is an increasing demand in the pharmaceutical and biotech industries for qualified pharmacovigilance professionals. Our courses in this area are designed to meet this demand, offering you a specialized understanding of pharmacovigilance issues based on a practical industry approach.

Focused courses

You can take individual courses or engage in a flexible, part-time postgraduate programme. Eight individual courses cover key stages of a drug’s lifecycle and aim to satisfy the educational needs of practicing pharmacovigilance professionals.

Experience:
Our diploma modules require a minimum of 2 years of experience in pharmacovigilance or another relevant area, or experience in the pharmaceutical/biological area that qualifies you to benefit from the training. We consider applicants with less than two years of experience on a case-by-case basis.

Introductory courses:
Introduction to Drug Safety & Pharmacovigilance

Diploma modules – can be taken as individual modules:
Principles of pharmacovigilance (Module 1)

Pharmacovigilance systems master file (Module 2)
Pharmacoepidemiology (Module 3)
Post-marketing surveillance (Module 4)
Pre-clinical and clinical aspects of pharmacovigilance (Module 5)
Pharmacovigilance data in application and registration (Module 6)
Adverse drug reactions by body systems (Module 7)
Veterinary pharmacovigilance (Module 8)

Design your own programme

Through our pharmacovigilance department, you can design your own diploma. You can attend individual courses in random order in a way that suits your home or work life. To earn the Diploma in Pharmacovigilance, you must pass five courses, one of which may include a course from the regulatory affairs programme.

Developed by

Our courses have been developed as a collaboration between a team of internationally renowned pharmacovigilance experts from the pharmaceutical and biotech industries, the Danish Medicines Agency and researchers from the Faculty of Pharmaceutical Sciences, University of Copenhagen. 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.

Faculty

The faculty comprises international experts from the pharmaceutical and biotech industries, authorities and universities.

Learning activities include class teaching, self-studies, interactive discussions, case studies and workshops. Each course is concluded with an examination approximately 4 weeks after the course.

Faculty board members

Karsten Lollike, Corporate Vice President & QPPV, Global Safety Management, Novo Nordisk AS
Doris Stenver, Chief Medical Officer, Pharmacovigilance Risk Assessment Committee Delegate, Danish Health and Medicines Authority
Morten Andersen, Professor in Pharmacovigilance, Department of Medicine and Pharmacology, Copenhagen University
Mette Philipsen, Country Safety Lead, Pfizer Denmark
Janne Malene Kampman, EU QPPV, Senior Director, GPV Safety Surveillance, H. Lundbeck A   
Karen Holm, Medical Information and Pharmacovigilance Manager, Sanofi
Lene Holdrup, Senior Director, QPPV, Global Pharmacovigilance, Ferring Pharmaceuticals A/S
Jesper Hallas, Professor in Clinical Pharmacology, University of Southern Denmark
Ellen Ravn Englev, Director, Case Management Department, Safety Operations, Novo Nordisk A/S
Christina Louise Schmidt, Med Info & Patient Safety Officer / Deputy Responsible Pharmacist, AstraZeneca A/S

  

Want to know more?

Contact Programme Director Gitte Hornemann Møller at +45 39 15 09 20

Send an email