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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
EMA Explains Dos And Don’ts Of New Clinical Trials Portal
Drug companies will be able to “play around” with the new EU Clinical Trials Information System in a secure testing environment before it goes live in approximately 15 months.
New Canadian Rule Allows Rolling Data Submissions For COVID-19 Drugs, Vaccines
The Canadian authorities have put in place an expedited pathway for authorizing new COVID-19 drugs and vaccines that offers a more agile approach to reviewing data than what was previously allowed.
UK To Use COVID-19 Learnings To Speed Up Review Of Other Trials
A new pre-assessment service for COVID-19 clinical trials that was established by the UK medicines regulator to cut down on review times is being extended to a limited number of other kinds of trials.
EMA Aims For Better Info On Benefit-Risk Balance To Support Drug Choices In Pregnancy
The European Medicines Agency is developing a strategy to ensure that women have sufficient information to make informed choices about taking medicines during pregnancy and breastfeeding.
Study Shows RWD Can Replace Placebo Data In Duchenne Trials
A first-of-its-kind collaborative study has found that real-world and natural history data are comparable to placebo data from clinical trials in Duchenne muscular dystrophy.
EU Panel Sets Ambitious Big Data Workplan
An EU group has listed several ambitious projects to help EU regulators realize their cherished vision of using big data capabilities to support innovation and public health. But these proposals may take a backseat as COVID-19-related challenges continue.