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
As part of efforts to “renovate” its good clinical practice (GCP) framework, the International Council for Harmonisation has framed new overarching GCP principles that can be applied to diverse trial types and data sources.
The 2021 work plan of PIC/S, the international group of pharmaceutical inspectorates, includes renewed efforts to carry out projects that could not be completed due to the coronavirus pandemic.
After agreeing on an EU-wide harmonized approach to deal with nitrosamine contamination in medicines, a recently formed regulatory oversight group has identified several topics requiring further scientific discussion.
After preliminary discussions with its pandemic task force, the European Medicines Agency has begun reviewing GSK/Vir Biotechnology’s promising COVID-19 treatment to help EU national competent authorities make evidence-based decisions on its possible early use.
Coronavirus Notebook: New EMA Review To Contextualize Blood Clot Risk From AZ Jab, EU Gets Earlier Access To More Pfizer Vaccines
Denmark has stopped using the AstraZeneca vaccine completely, while the Canadian regulator is not recommending restrictions in any specific populations. Can a new EMA review provide better context to guide the vaccine’s use in different age groups and gender?
After agreeing on an EU-wide harmonized approach to deal with nitrosamine contamination in medicines, a newly-created regulatory oversight group has identified several topics requiring further scientific discussion.