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.
Latest From Vibha Sharma
EU reviewers have recommended marketing approval for two new medicines, but have turned down another product.
The European Medicines Agency is meeting this week to consider applications to broaden the use of approved drugs to include new indications in the EU.
The marketing application for obeticholic acid, Intercept’s potential new treatment for advanced fibrosis due to nonalcoholic steatohepatitis (NASH), was rejected in the US and now the company says it needs extra time to respond to questions about its EU filing.
The European Medicines Agency is meeting this week to decide whether two new drugs, including one that enhances anti-parkinsonian activity, should be approved for use in the EU. Also, the sponsor of a treatment for the rare degenerative muscle disorder, Pompe disease, is expected to attend an oral explanation meeting to address last-minute questions.
The international association of pharmaceutical inspectorates, PIC/S, has developed a structured process that national inspectors can use to assess their risk of exposure to COVID-19 when carrying out routine on-site inspections.
Companies approaching the European Medicines Agency with their development plans for new COVID-19 vaccines are being asked to consider immunobridging studies if placebo-controlled trials are not feasible.