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 regulator has done a good job of aligning its final data integrity guideline with those of other international bodies, which means global drug companies will not have to balance competing requirements to achieve compliance, says consultancy firm Rammell. However, some aspects of the guideline, such as following a risk-based approach, could pose some challenges.
The Malaysian medtech regulator has issued a new circular and a related draft guidance to facilitate the export of medical devices manufactured by original equipment manufacturers.
A reflection paper being drafted by the European Medicines Agency is seeking to eliminate the current variability relating to how therapeutic indications are defined in the summary of product characteristics.
After an initial rejection, Roche's IL-6 drug RoActemra has received support from the UK's health technology assessment body to treat giant cell arteritis in a subset of patients, provided the treatment with the drug is permitted for one year at the most.