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.
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Vibha Sharma
A number of companies were due or potentially due to appear before the European Medicines Agency’s drug evaluation committee, the CHMP, this week to answer questions in person about their marketing applications.
A month after being asked to attend an oral explanation meeting with the European Medicines Agency, Paratek Pharmaceuticals has decided to withdraw the EU marketing application for its broad spectrum antibiotic, Nuzyra. The company is one of two drug sponsors that has withdrawn an EU marketing application in October.
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?
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.
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.
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.