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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
An EU guideline on the complex subject of how drug sponsors should present and manage the reference safety information in their clinical trial applications is nearing finalization. For the past several months, drug companies have been grappling with an increased regulatory focus on RSI, which has resulted in their trial applications being rejected or studies being significantly delayed.
A senior official at the European Medicines Agency has warned pharmaceutical companies are taking a risk by endlessly waiting to get news on whether there would be a Brexit transition period. Drug makers still waiting to prepare for changes that may be needed once the UK leaves the EU were told 'this is your risk and your decision.'
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-eight new guidance documents were posted to the tracker.
The European Medicines Agency is revising its signal management guideline to clarify several terminologies and offer flexibility to help companies comply with their legal obligation to monitor the revamped EudraVigilance database. The biggest relief for the industry is that the new procedures in the guideline will be initially tested on a small number of products.
The European Medicines Agency is having to shut down some of its systems for two weeks in order to have the revamped EU pharmacovigilance database up and running for 9am on Nov. 22. The shutdown will affect the reporting of adverse drug reactions as well as some aspects of other processes such as submission of periodic safety reports and marketing authorization applications. Companies will have to be vigilant as arrangements will vary from country to country.
Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker.