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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

Dutch Hospital Resumes Own Manufacture Of Leadiant’s Costly Drug

While the Dutch government negotiates an acceptable price for Leadiant Biosciences’ orphan drug CDCA, a university hospital has resumed supplying pharmacy compounded versions of the drug after addressing initial problems with the sourcing of raw materials.

Netherlands Manufacturing

Big Win For EMA On Transparency

The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.

Europe Clinical Trials

EU Countries Test Offering Simultaneous Scientific Advice

An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.

Innovation Regulation

EU Panel Outlines Practical Way Forward With Big Data

An ambitious action plan drawn by an EU task force, if implemented on a priority basis by the European Commission, could increase the EU’s capacity to advise on, assess and analyze big data.

Real-World Evidence Drug Approval Standards

Switzerland Fast Tracks Registration Of EU/US-Approved Anti-Infectives

Swissmedic will scale back its review procedure for certain anti-infectives if the indications for which approval is being sought are identical to those approved in the EU or the US.

Switzerland Drug Approval Standards

EU Makes ISO Format Mandatory For Side-Effect Reporting From June 2022

Based on the operational experience gained using the new international standard for reporting suspected adverse reactions in EudraVigilance, the EU has decided to set a date for its mandatory use.

Europe Regulation
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