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Vibha Sharma
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
EMA Points To Potential Sources Of Nitrosamine Contamination
As companies evaluate scores of products for the possible presence of nitrosamine impurities, the EU regulator has listed potential sources of contamination identified to date to help sponsors develop a risk-based approach for their evaluations.
EMA Identifies Potential Sources Of Nitrosamine Contamination
As companies evaluate scores of products for the possible presence of nitrosamine impurities, the EU regulator has listed potential sources of contamination identified to date to help sponsors develop a risk-based approach for their evaluations.
First Ebola Vaccine Among Seven Products To Get EMA Nod
Seven new products, including the world’s first ever Ebola vaccine, are on track to receive EU-wide approval. Meanwhile, two drugs have failed to make the grade.
UCB Pharma Among Latest Sponsors Up For CHMP Oral Explanations
A number of companies were due or potentially due to appear before the European Medicines Agency’s drug evaluation committee, the CHMP, this week to answer questions in person about their marketing applications.
All Or Nothing: Paratek Withdraws EU Filing For Nuzyra
A month after being asked to attend an oral explanation meeting with the European Medicines Agency, Paratek Pharmaceuticals has decided to withdraw the EU marketing application for its broad spectrum antibiotic, Nuzyra. The company is one of two drug sponsors that has withdrawn an EU marketing application in October.
Daiichi Sankyo’s AML Drug Among Nine CHMP Hopefuls
Will regulators in the EU follow their US counterparts in requiring more efficacy data for Daiichi Sankyo’s acute myeloid leukemia drug quizartinib, which is already approved in Japan?