Masterarbeit

Assessment of European Union referral procedures (human, post-authorisation) triggering the implementation of risk minimisation measures as outcome after European Commission decision

Meike Herrmann (2020)

Summary
Language: English
This thesis shows the risk minimisation measures as outcome of EU article-31 community referral and article-107 urgent union procedure over the last years.
The referral procedure is a regulatory initiative for (group of) substances to assess their benefit-risk balance, triggered by PRAC, considering as well risk minimisation measures. The implementation of aligned risk minimisation measures by the marketing authorisation holder(s) is mandatory for all EU/EEA countries where the medicinal product is authorised.
More often various stakeholders, e.g. healthcare professionals and patients, were involved to share and learn from experiences, to explain proposals and is discussed in this thesis as an opportunity for critical medicinal products.
The risk minimisation measures cover various tools which are evaluated in a referral procedure or during the authorisation process. The target is to minimise risks and prevent patients, healthcare professionals from harm. The risk minimisation measures are grouped into routine and additional.
This thesis explains the routine and additional risk minimisation measures and discuss the process supporting the decision and implementation of a (group of) risk minimisation measure(s) related to a (group of) substance(s) and importance to determine process and outcome indicators to review the effectiveness.
Pages: 54