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 report that identified several shortcomings of the European Medicines Agency fee system, the European Commission has suggested various options to make it sustainable and future-proof.
Medical device regulators around the world have proposed new guidance for designating conformity assessment bodies because requirements in existing international standards are too generic.
The pharmaceutical industry is concerned that too much flexibility may result in a “fragmented and cost intensive implementation” of the EU electronic product information framework.
Canada’s R&D drug industry says it approached the court as a “necessary step,” given the significant impact of the pricing reforms.
EU pharma is concerned that certain proposals in a new international guideline on bioanalytical method validation could be overinterpreted, increase burden on companies and stifle ‘scientific freedom.’
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.