Masterarbeit

Educational material as important risk minimisation measure and procedure of agreement with the competent authority ***

Dr. Melanie Schüppel (2014)

Summary
Language: English
Since 2005 the pharmacovigilance legislation has shifted pharmacovigilance from a largely reactive approach to a continuous proactive approach based on a continuous benefit-risk assessment including proactive risk management. The present thesis describes the implementation of the general principles of risk management in the pharmacovigilance context. The risk management plan is the crucial instrument by which marking authorisation holders intends to identify, measure, monitor and manage the risks of a specific medicinal product. Apart from routine activities, additional risk minimisation measures may be warranted. The present thesis shows that these additional measures become more and more important, whereas educational material is the predominant strategy for additional risk minimisation in the EU.
The current requirements for educational material have been reviewed, especially in light of their feasibility from an industry’s perspective.
Due to the fact that only key elements are made condition of the marketing authorisation, it is the responsibility of the national competent authorities to ensure that any risk minimisation measure including educational material is implemented in line with these key elements. From an industry’s perspective, the national procedures for obtaining agreement on national educational material could be a prerequisite for product introduction. Thus, the national requirements for submission and approval of national educational material in Germany, France, Sweden, the Netherlands and UK have been compared and evaluated in the present thesis.
Moreover, the overall value of educational material to attain changes in knowledge and behaviour of healthcare professionals and patients has been critically discussed.
Taking into account that risk minimisation is a global approach, the European strategies on risk minimisation have been opposed to the ones in the US in order to share best practice. This is of special interest regarding the requirement for evaluation of effectiveness of additional risk minimisation measures which might become the most critical but at the same time the most difficult step since the introduction of risk management plans in the EU.
Pages: 77, Annexes: 15 pages