EU rules for assignment of Local Contact Person for PharmacoVigilance (LCPPV) and Local Literature Search (LLS) are a constant source of confusion. The Industry are… Read more »
Read MoreIf you ever wonder which the different user access categories are when setting up users in EVWEB and the EMA User Access Portal then this… Read more »
Read MoreThe MHRA published updated PV guidance on its website on 28-OCT-2022. The changes involve updates regarding further details on submission requirements for the MHRA, in… Read more »
Read MoreEuropean Medicines Agency (EMA) requires the Marketing Authorisation Holders (MAHs) to register an Industry Single Point of Contact (i-SPOC). This is to inform the EMA… Read more »
Read MoreAdverse Events of Special Interest is an important concept in management of safety risks for medicinal products and vaccines. The is no single definition of… Read more »
Read MoreMHRA has again issued inspection metrics which has a lot interesting information. Note that the number of for cause inspections is high The UK’s national… Read more »
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