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
As companies undergo pharmacovigilance inspections from a growing multitude of regulatory authorities from around the globe, a senior pharmaceutical industry executive discusses how her company has been handling this complex and challenging task.
While inspection interviews can be stressful for drug firms, a Dutch pharmacovigilance inspector reassures companies that any responses made during the process cannot undo any good work they have already done. And they can also correct any wrong answers later on.
The Saudi Food & Drug Authority looks at the number of individual case safety reports (ICSRs) submitted by a company, among other risk-based factors, when drawing up its list for routine pharmacovigilance inspections.
Based on its experience of reviewing tools used by companies for additional risk minimization, the European Medicines Agency is planning to update its guidance on this topic with more information on how these tools can be better employed.
The International Council for Harmonisation is making big changes to its E19 guideline that proposes taking a targeted approach to safety data collection in some late-stage clinical trials. The draft guideline, which is largely similar to the US guideline on this topic, drew varied comments from stakeholders, including those from the EU.
In the second segment of a two-part article on the use of artificial intelligence in pharmacovigilance, a senior UK regulator and representatives from the pharmaceutical industry discuss new skills that drug safety professionals must acquire as companies increasingly embrace AI tools.