Masterarbeit

The impacts of EudraVigilance enhancement on signal detection - from the perspective of pharmaceutical industry ***

Dr. Yan Xu (2017)

Summary
Language: English
Signal detection and its assessment is the core safety aspect in pharmacovigilance which plays a key role in protecting patient and meeting regulatory compliance. Due to limitations of pre-marketing clinical trials – limited number of the patients studied, narrow population (strict inclusion/exclusion criteria) and short duration, there is normally not sufficient information available at the time that a medicinal product is authorised for marketing. The (incidence of) rare adverse events (AEs), events with significant latency, drug-drug/food interactions, specific groups (elderly, pregnant women or high risk individuals), increased severity and / or incidence of known reactions, can only be detected and evaluated during post-marketing phase. Therefore signal management shall be an on-going activity spanning the lifecycle of a medicinal product, both in pre- and post-marketing authorisation.
Safety signals can be detected from diverse sources such as spontaneous adverse drug reaction (ADR) reports, clinical studies and scientific literature. Large databases such as the EudraVigilance database are important sources of ADRs and signals.
On 22nd November 2017, the European Medicines Agency (EMA) launched the new version of EudraVigilance with enhanced functionalities. Along with the new EudraVigilance, access to the EudraVigilance Data Analysis System (EVDAS) is granted to the marketing authorisation holders (MAHs) in the European Economic Area (EEA). Hence, one of the biggest challenges for the MAHs is to figure out how to adjust their signal management activities in compliance with the new system and how the processes of signal detection should be performed in the new EudraVigilance.
This master thesis gives an overview of the principles of signal detection and the changes to EudraVigilance and intends to find out the way meeting the EMA guideline on signal detection.
Pages: 57, Annexes: -