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
A new evaluation route that the European Medicines Agency launched last year came at the right time for Takeda’s dengue vaccine candidate.
Executive Summary: The European pharma industry federation believes the advice provided in the updated draft EU guideline on additional risk minimization measures is far too detailed, resulting in a lack of focus, information overlap and confusion.
At its latest meeting in June, the International Council for Harmonisation agreed on new topics that could benefit from harmonized advice and took note of progress made on drafting and finalizing quality, safety and multidisciplinary guidelines.
COVID-19 is driving changes to how clinical trials are being conducted in the US, with 44% of respondents who participated in a recent survey saying they have adapted or plan to become decentralized in coming months.
Having gained enough experience with the combined ethics and regulatory review of clinical trial applications, the UK will make this its only route for evaluating new drug trial applications starting next year.
Stakeholder agreement on the technical features of electronic product information (ePI) will pave the way for launching a proof-of-concept exercise and a roadmap on how ePI will be rolled out in the EU.