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Vibha Sharma

Vibha Sharma is a senior reporter covering pharmaceutical and medtech regulatory developments across the globe. She joined Scrip Regulatory Affairs in September 2010 and has since then been at the center of deciding and writing news on important regulatory issues affecting the pharma and medtech sectors and explaining their implications for the industry.

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

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 The company is one of two drug sponsors that has withdrawn an EU marketing application in October.

Europe Drug Review

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?

Drug Review Approvals

UK Tackles GCP Concerns Over Electronic Health Records

As NHS Trusts switch from paper-based to electronic health records, concerns have arisen about the compatibility of EHR systems with the clinical trials legislation in some cases.

Clinical Trials Regulation

Disappointing End For MolMed’s Zalmoxis Cell Therapy In EU

MolMed decided to the withdraw the drug's conditional marketing authorization after Phase III clinical trial results showed that the drug offered no benefit on disease-free survival.

Europe Regulation

Nitrosamine Issue Presages Paradigm Shift In Quality

The detection of cancer-causing impurities in drugs with well-established safety profiles may force regulators across the globe to revise their approach for evaluating quality.

Manufacturing Regulation
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