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.
Current position (as of March 1st 2019)
Consultant, founder of Unique Advice, an independent consultancy specialized in pharmacovigilance.
Chief Medical Officer, Danish Medicines Agency, Medical Evaluation and Biostatistics.
1986 Medical Degree from Copenhagen University, the Faculty of Medicine
1995 Specialist in Internal Medicine
2007 Master Degree in Public Administration, Copenhagen Business School
During 12 years (July 1986 – May 1998) she worked as a physician at university hospitals in the Copenhagen area (Hvidovre, Frederiksberg, Herlev, Roskilde), primarily in departments specialized in internal medicine, nephrology and endocrinology. In 1995 she became specialist in internal medicine. Her clinical experience also covers haematology, cardiology and infectious diseases. Her research activities and publications were primarily within the areas of haematology, immunology, nephrology and endocrinology.
She joined the Danish Medicines Agency in June 1998, initially as senior medical officer; in 2002 appointed chief medical officer. She was member of the EU Pharmacovigilance Working Party from June 1998 until July 2012. From July 2012 until end of February 2019 she was member of the Pharmacovigilance Risk Assessment Committee (PRAC). Her regulatory experience comprises all aspects of pharmacovigilance, including scientific evaluation of drug safety issues, development of risk management strategies, policies and guidelines, provision of scientific advice to the pharmaceutical industry, and communication to health care professionals and the public. Author of several international publications on various aspects of pharmacovigilance. Experienced conference speaker and moderator.