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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

Heart Rhythm Concerns Prompt EU-Wide Suspension For Fenspiride Cough Medicines

Fenspiride medicines are being suspended while the European Medicines Agency's pharmacovigilance committee carries out an urgent safety review to address concerns that these drugs can cause sudden serious heart rhythm problems.
Drug Safety Respiratory

Canada Decides Against Suffix-Based Biologics Naming System

Following a consultation with stakeholders, the Canadian regulator says identification of biologics using their brand and non-proprietary names has emerged as the most preferred option as it is consistent with current practice.
Canada Biologics

Wait For Benefits Of EudraVigilance Pilot Before Expanding To More EU Products, Says Pharma

Drug companies say that any decision on taking the EudraVigilance monitoring requirements into the next phase should only be made when there is clear evidence that it has improved patient safety.
Europe Regulation

Global Regulators Promote Convergence With New Biowaiver Evaluation Template

An international group of pharmaceutical regulators has issued a new template that can be used to assess biowaiver applications for additional drug strengths.
International Generic Drugs

Australia Consults On Upclassifying Spinal Implants In Line With EU

The Australian regulator has proposed adopting the EU's approach to classifying spinal implantable medical devices as high-risk products and has suggested a four-year transition period to cover all affected devices on the market.

Australia Safety

Australia Considers Changes To Bioequivalence Requirements For Foreign Comparators

Changing Australian requirements on showing equivalence with an overseas reference product used in bioequivalence studies, and introducing a new early scientific advice service for biowaiver proposals, are among key proposals made by the Therapeutic Goods Administration as part of reforms in the generic medicines sector.
Australia Generic Drugs
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