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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

WHO's Human Genome Editing Standards Must Not Impact Somatic Cell Research

Concerns have been expressed that efforts by the World Health Organization to establish global standards for the whole spectrum of human genome editing research may inadvertently have a negative impact on companies developing somatic cell therapy medicinal products.
International Regulation

ICH Consults On Guideline To Improve Bioanalytical Data Consistency

The finalization of a new international guideline that proposes a harmonized approach on bioanalytical method validation is expected to reduce the need for additional validation experiments and support streamlined global drug development.
International Regulation

Saudi FDA Consults On Compassionate Use Program Requirements

The Saudi drug authority has clarified the roles and responsibilities of the various players involved with giving patients access to drugs under development on compassionate grounds.
Saudi Arabia Regulation

Danish Agency Claims A First In Raw Data Analysis

The Danish Medicines Agency says it is about time that EU regulators developed US FDA-style capabilities to analyze raw data so that they can make better use of the opportunities provided by big data. Agency chief Thomas Senderovitz tells Medtech Insight how Denmark is setting up a unique data analytics center for medical devices and drugs without reinventing the wheel.

Denmark Europe

Danish Agency Claims A First In Raw Data Analysis

The Danish Medicines Agency says it is about time that EU regulators developed US FDA-style capabilities to analyze raw data so that they can make better use of the opportunities provided by big data. Agency chief Thomas Senderovitz tells the Pink Sheet how Denmark is setting up a unique data analytics center for drugs and devices without reinventing the wheel.
Denmark Europe

Hong Kong Clarifies Rules On Local Responsible Persons To Facilitate Device Listings

Hong Kong has issued new guidance and an updated code of conduct on the roles and responsibilities of entities wanting to be listed as a local responsible person.

Hong Kong Regulation
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