In this presentation the focus will be on the activities of the Pharmacovigilance Risk Assessment Committee (PRAC), including current safety topics of particular importance on the PRAC agenda. The mandate of the PRAC covers a wide range of procedures, e.g. referrals, PSURs, RMPs, signals. In order to achieve the best possible impact of pharmacovigilance it is important to choose the most appropriate procedure to further evaluate a safety concern. The main purpose of the different procedures is highlighted and illustrated by case examples and their outcomes. As part of the workplan PRAC is dedicated to further develop its strategy for measuring the impact. This strategy comprises several different tracks, e.g. revision of the framework for impact evaluation, optimization of data collection for impact measurement, further developing the methodology for health impact assessments, engagement with patient and health care communities and capacity building and development of a process for identifying relevant public health outcomes. The presentation will attempt to provide an overview on these planned activities and - as far as possible – provide a status of the future directions.
Graduated from Copenhagen University, the Medical Faculty, in 1986 she became specialist in internal medicine in 1995.
Following 12 years employment at university hospitals in the Copenhagen area she joined the Danish Medicines Agency in 1998 and was appointed Chief Medical Officer in 2002.
She was member of the Pharmacovigilance Working Party 1998 – 2012 and of the Pharmacovigilance Risk Assessment Committee from July 2012 until February 2019.
Her experiences cover all aspects of pharmacovigilance, including the legal framework, scientific and strategic aspects and communication.
In 2007 she achieved a master degree in public administration from Copenhagen Business School. In March 2019 she founded the independent consultancy Unique Advice, specialized in pharmacovigilance.