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
The UK government’s response to the Accelerated Access Review report is on hold until after the snap general election in June.
As the European Medicines Agency starts to address the findings of a report that questions the wisdom of granting lengthy deferrals for neonatal studies, an industry expert warns that by requiring such studies to be initiated earlier, the agency may come into conflict with ethics committees.
The European Medicines Agency is examining its current experience with granting deferrals for studies mandated under the EU Paediatric Regulation, and is re-considering when it is most appropriate to grant deferrals for neonatal studies.
Changes have been proposed to EU guidance that explains what warnings drug companies should include in their package leaflets and labels for certain excipients.
Even though the European Medicines Agency has not found any safety concerns in relation to 43 external complaints of alleged improprieties affecting medicines received since 2013, it has adopted a new policy to deal with such reports in a consistent manner.
The EU is funding a €1.1m project to help Moldova improve its regulatory capacity so that it is on the same footing as medical product regulators in the EU member states. The project builds on a 2014 “association agreement” signed between Moldova and the EU under plans to gradually integrate the south east European candidate country in the EU's internal market.