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
Changes to an ICH guideline could help drug companies that are being deluged with post-approval safety information to cut down on noisy, low-value data.
European Medicines Agency plans to finalize changes to its guideline on additional risk minimization measures and then establish a new drafting group on digitalization of education materials.
A senior MHRA inspector explains the nuanced differences between the newly created UK roles of qualified person for pharmacovigilance and national contact person to help companies position the two individuals appropriately within their organizational structures.
A senior MHRA inspector says some companies are not clear about the structuring and content of the pharmacovigilance system master file needed for UK authorized products.
A senior AstraZeneca executive gives a candid account of how the company recovered from the unexpected deluge of safety reports for its COVID-19 vaccine.
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.