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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.
Latest From Vibha Sharma
PIC/S Supplements GMP Guidance On Cross Contamination In Shared Facilities
The international group of pharmaceutical inspectorates, PIC/S, has issued an aide-memoire and a Q&A document to support its 2018 guideline on using health-based exposure limits to assess the risk of cross contamination in shared manufacturing facilities.
Global Pharma Guidance Tracker – May 2020
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.
Global Medtech Guidance Tracker: May 2020
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-one guidance documents have been posted on the tracker since its last update.
Pharma Snubs WHO Call To Pool COVID-19 Patents
Almost three dozen countries have shown support for the alternative mechanism put forward by the World Health Organization to ensure that IP issues do not stand in the way of providing access to COVID-19 medicines, vaccines and diagnostics to ‘all of humanity.’
EMA Creates Internal Repository To Support Regulatory Consistency
Regulatory and scientific discussions undertaken by the European Medicines Agency’s human medicines evaluation committee are finding their way into a new internal repository.
EMA Offers Simultaneous Review Of Products For EU And Non-EU Markets
Companies can have their EU centralized marketing authorization application and submission for an Article 58 opinion (on medicines for use in non-EU countries) reviewed in parallel by the European Medicines Agency. The simultaneous assessment can be helpful when drugs and vaccines are needed for both EU and non-EU populations.