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Vibha Sharma
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
Roche’s Polivy Among Seven New Drugs On Track For EU-Wide Approval
Seven drugs, including two orphans and two generics, are on track to receive pan-EU approval.
New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
EU Explains How Info Requests Will Be Managed Under Clinical Trials Regulation
Updated guidance on the upcoming EU Clinical Trials Regulation deals with requests for information from the regulators and how strict timelines for evaluating clinical trial applications will be adhered to.
Another Ebola Vaccine Among New Filings At EMA
The European Medicines Agency has received 11 new marketing authorization applications, including three for orphan products from Vertex, MYR Pharmaceuticals and AstraZeneca.
Problems With Drug Absorption Studies Still ‘Relatively Common’ In EU
A retrospective analysis of new drugs evaluated by the European Medicines Agency since 2010 shows that a lack of, or major deficiencies in, human mass balance studies is still a concern in regulatory submissions.
Global Pharma Guidance Tracker – October 2019
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.