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 MoreIn a clinical trial, the description of risks must be written in lay language and at an 8th grade level. Learn how AI can help translate complex risks.
Read MorePharmacovigilance, the science and practice of monitoring and evaluating the safety and effectiveness of medications, is critical for safeguarding public health. With the increasing complexity… 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 »
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