Her fields of interest include the EU Pharmacovigilance legislation and the EU Paediatrics Regulation on which she has written several exclusive articles from various industry conferences. She has also commissioned some pieces of expert analysis on major developments in the pharma and medtech regulatory arenas.
Before joining Informa, she was principal correspondent with India's national newspaper Hindustan Times, where she reported on health and medical issues, besides several other topics. She has also worked with two other Indian national dailies, The Indian Express and The Asian Age.
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Latest From Vibha Sharma
Following a resurgence of activity in the field of antibacterial products, the European Medicines Agency has proposed merging and updating its two existing guidelines on this topic into a single, clearer, core document.
The EU's regulatory coordination group, the CMDh, is concerned that some companies are submitting parallel marketing authorization applications under national procedures, creating more workload for EU national competent authorities. It is investigating why these submissions are not being routed through the mutual recognition/decentralized procedures, which are best suited for such applications.