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.
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Latest From Vibha Sharma
The European Medicines Agency is exploring the possibility of establishing minimum requirements for all CAR-T Cell registries in the EU to facilitate efficient data collection on such products in the post-authorization phase.
A joint evaluation of the EU pediatrics and orphan drugs legislation is due to commence next year in an effort to understand why the two legal instruments have failed to encourage companies to develop medicines targeting rare diseases in children. The initiative will help decide the possible need for future changes.
Several factors have contributed towards a delay in the European Medicines Agency's much awaited guideline on investigational advanced therapy medicinal products, which was initially due to be finalized in the second quarter of 2017.
The European Commission has developed a database to help drug companies navigate the complex process of seeking environmental clearance from EU member states before they can initiate a clinical trial with ATMPs containing a genetically modified organism.
Sponsors of medicines evaluated through the EU's decentralized procedure are being urged to share their plans regarding Brexit with national agencies as soon as possible to help with planning. The head of the Dutch Medicines Agency thinks that the human medicines sector can learn from the progress being made in the veterinary space on this front.
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