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...ver, assessing the expected future value of the medicines when used in “real world” clinical practice requires additional information next to traditional (pre-authorisation) clinical trials. Regulatory, HTA agencies and other healthcare decision makers have to make decisions on authorisation and access under conditions of uncertainty. Currently, data packages which aim to minimise uncertainty on ...

Recent pharmacovigilance (PV) issues have led to questions regarding the ability of the current PV system to meet the global needs. Controversies around the assessment of spontaneous reports and conflicting results from pharmacoepidemiology studies may lead to delay in, or inappropriate, regulatory decisions. The PROTECT consortium, consisting of 20 core partners lead by the European Medicines Age ...