Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Implementing the new Pharmacovigilance legislation - challenges for the pharmaceutical industry ***
Dr. Dagmar Behnke (Abschlußjahr: 2016)
Summary
Language: English
"Pharmacovigilance has been defined by the World Health Organisation (WHO) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem." 1
Key to prevention of harm to an individual patient, as well as to minimising the risk for public health, is the continuous monitoring of various sources of adverse reactions occurring during the use of an authorised medicinal product, to assess the potential risks of a medicinal drug and to communicate safety issues to authorities, healthcare professionals and patients in a timely and adequate manner.
Following the outcome of an independent study on the EU system of PhV2 and a public consultation on the Community system of PhV in 20063, it was decided that the EU PhV system needed "rationalisation and strengthening". Unclear roles and responsibilities, differences on national level and "a lack of robust safety studies" led to the decision to improve the PhV system in the EU.
"We will improve and strengthen the monitoring of the safety of medicines so that safety issues are rapidly detected, and effectively dealt with based on more robust data. Rationalisation of the EU medicines safety system will free up resources which can then be directed to better protecting the health of EU citizens."
(Günter Verheugen, Commission Vice President, 2007)
Consequently, to enhance and strengthen pharmacovigilance as well as safety of patients and public health in Europe, a new legislation was adopted in 2010 and came into force in July 2012.
This thesis is presented as a résumé of the issues arising during implementation of the new PhV legislation to provide insight into and understanding of the challenges imposed upon the pharmaceutical industry as exemplified for medac Gesellschaft für klinische Spezialpräparate GmbH.
Pages: 67
1 Guidelines on good pharmacovigilance practices (GVP), EMA/136477/2016
2 Assessment of the European Community System of Pharmacovigilance, Final report – Final version, Fraunhofer Institute Systems and Innovation Research, Karlsruhe, Germany, 25 January 2006
3 Commission Public Consultation: An Assessment of the Community System of Pharmacovigilance, http://ec.europa.eu/health/files/pharmacovigilance/docs/acs_consultation_final_en.pdf, March 2006