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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

EMA 'Completely Reworks' Parts Of Gene Therapy Products Guideline

The European Medicines Agency has revised several sections of its 2001 guidance on the development and evaluation of gene therapy medicinal products based on stakeholder feedback and to address issues in light of the experience gained with these products.

Europe Regenerative Medicine

Canada Makes It Mandatory For Pharma To Report Overseas Safety Actions

Canada claims to be the first country to issue formal regulations that make it mandatory for drug companies to report within strict timelines safety issues related to their products in certain foreign jurisdictions.
Canada Drug Safety

EMA Consults On Filling Guidance Vacuum For Acute Kidney Injury Medicines

The European Medicines Agency says that guidance is needed on how to develop medicines for preventing or treating acute kidney injury, the prevalence of which is increasing.  

Europe Clinical Trials

EMA To Contact Sponsors Of Over 100 Drugs At Risk Of Shortage Post Brexit

The European Medicines Agency’s survey on industry’s preparedness for Brexit has raised serious concerns about the continued supply of 108 drugs that have manufacturing operations based solely in the UK.

Europe United Kingdom

Updated EU Guide On Safety Features Addresses Parallel Trade Repackaging

The EU guideline on complying with the requirement to affix safety features on medicine packs has been updated to address specific aspects of parallel trade, such as re-sealing of medicine packs that are legally opened to replace patient information leaflets.

Europe Regulation

EMA's Modeling & Simulation Group Gears Up For Bigger Role With New Status

Modeling and simulation approaches are expected to play even a greater role in regulatory decision-making by the European Medicines Agency in the coming years.
Europe Regulation
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