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
The UK MHRA has approved its first drug under an international work-sharing initiative that also includes regulators from Australia, Canada, Singapore and Switzerland.
Consultancy firms must have at least five years of experience in carrying out independent GMP or GDP audits if they want to apply to become a “compliance monitor” under a new MHRA scheme to keep track of drug companies that fail to comply with GMP/GDP requirements.
The digitalization of clinical trials is generating more patient safety data than companies can process. A senior EMA official says sponsors should carefully select what is needed to maintain appropriate subject oversight by “getting the science right.”
A senior regulator from the European Medicines Agency says that while the EU General Data Protection Regulation can be intellectually challenging, the law is needed, and it should not deter companies from conducting decentralized clinical trials because of concerns they might have over the use digital tools to capture and process patient and trial data.
A senior EMA official says companies should use “a little imagination” when confronted with EU member state-specific barriers to decentralized trials and not “just freeze in front of the headlights.”
While Defitelio is not authorized in the EU for the prevention of veno-occlusive disease (VOD), the European Medicines Agency wants health professionals to be informed about the results of a recent study in which the drug showed no benefit in this indication.