Vibha Sharma
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
Daiichi Sankyo’s AML Drug Among Nine CHMP Hopefuls
Will regulators in the EU follow their US counterparts in requiring more efficacy data for Daiichi Sankyo’s acute myeloid leukemia drug quizartinib, which is already approved in Japan?
UK Tackles GCP Concerns Over Electronic Health Records
As NHS Trusts switch from paper-based to electronic health records, concerns have arisen about the compatibility of EHR systems with the clinical trials legislation in some cases.
Disappointing End For MolMed’s Zalmoxis Cell Therapy In EU
MolMed decided to the withdraw the drug's conditional marketing authorization after Phase III clinical trial results showed that the drug offered no benefit on disease-free survival.
Nitrosamine Issue Presages Paradigm Shift In Quality
The detection of cancer-causing impurities in drugs with well-established safety profiles may force regulators across the globe to revise their approach for evaluating quality.
MolMed Pulls Zalmoxis Cell Therapy In EU
The Italian biotech will redirect investment, initially reserved for Zalmoxis, to other activities that would better meet its business objectives.
Nitrosamine Episode Could Lead To Paradigm Shift In Quality
The detection of cancer-causing impurities in drugs with well-established safety profiles may force regulators across the globe to revise their approach for evaluating quality.