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 Consults On Proposed Framework For Patient Preference Studies
The EMA is inviting feedback on its plans to ratify, with some caveats, a new framework on how to use patient preferences as input in medical product decision-making. The framework was developed under the EU’s public-private Innovative Medicines Initiative.
Sweden Tackles Regulatory Barriers To Decentralized Trials
The COVID-19 pandemic has given a new impetus to Sweden’s ongoing efforts to support decentralized clinical trials.
UK To Up Transparency By ‘Auto Registering’ Trials
The UK Health Research Authority (HRA) has partnered with an international clinical trials registry to make it easier for sponsors and researchers to comply with the mandatory requirement of registering their studies in an established public database within a specific time frame.
EMA Consults On Proposed Framework For Patient Preference Studies
The EMA is inviting feedback on its plans to ratify, with some caveats, a new framework on how to use patient preferences as input in medical product decision-making. The framework was developed under the EU’s public-private Innovative Medicines Initiative.
UK To Up Transparency By ‘Auto Registering’ Trials
The UK says its initiative to unilaterally register clinical trials when they are given a research ethics committee approval will make it easier for trial sponsors to comply with their transparency requirements.
ICH Emphasizes Need For Quality In Clinical Trials
The International Council for Harmonisation has delivered the first of a two-part project to modernize the international good clinical practice framework by finalizing changes to its primary efficacy guideline.