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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

New PIC/S Guide Offers Framework For Voluntary Reliance On Foreign GMP Inspections

A new guideline has been adopted by PIC/S, the group representing international pharmaceutical inspectorates, to help regulators assess whether GMP compliance at foreign sites has been established by the hosting competent authority, without the need for an on-site visit.
Manufacturing Regulation

New Group To Resolve 'International Divergence' Posed By EU ATMP Guide

Pharmaceutical inspectorates around the world are trying to address the divergences between Europe’s good manufacturing practice guideline on gene therapy and tissue-engineered products and the international GMP guideline for such products.

Failure To Invest In Drug Repositioning Is Frustrating, Says EU Rare Disease Patients Group

Yann Le Cam, who heads the EU network of rare disease patient organizations, is calling for innovative solutions to support the 'repositioning' of existing and new medicines that could potentially treat orphan conditions but are not developed by companies due to business considerations.
Rare Diseases Europe

New NHS England Processes To Tackle Uncertainties And Delays In Setting Up Clinical Trial Sites

A new "standard charging methodology" is to be introduced across NHS England to allow drug and device clinical trials to get underway faster. Presently, there can be a difference of up to nine months between confirmations being issued by each NHS hospital taking part in a multi-site trial.

Clinical Trials Policy & Regulation

New NHS England Processes To Tackle Uncertainties And Delays In Setting Up Clinical Trial Sites

A new 'standard charging methodology' is to be introduced across NHS England to allow drug and device clinical trials to get underway faster. Presently, there can be a difference of up to nine months between confirmations being issued by each NHS hospital taking part in a multi-site trial.
Clinical Trials Regulation

Orphan Drugs Study Compares EMA's Significant Benefit With HTA's Relative Effectiveness Assessments

A first of its kind study is underway to look at how the significant benefit assessment of orphan products by the European Medicines Agency compares with relative effectiveness assessments by health technology assessment bodies.
Health Technology Assessment Regulation
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