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
Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.
The Australian health care products regulator is inviting feedback on proposed measures to clarify the boundary for software-based products that are captured under the regulatory framework for medical devices.
A draft EU guideline explains how companies can ensure that data from ongoing clinical trials remains relevant for regulatory decision-making despite problems posed by the COVID-19 pandemic.
The UK’s Medicines and Healthcare products Regulatory Agency is replacing all non-essential on-site inspections with office-based assessments due to the coronavirus pandemic. The agency also plans to rely on information from international regulatory partners to maintain oversight.
Regulators held a virtual meeting to agree on the type and extent of preclinical data needed to inform the clinical development of vaccines for COVID-19.
New EU guidance on managing clinical trials in the context of COVID-19 requires sponsors to critically assess the feasibility of starting a new clinical trial or including new participants in an ongoing trial. A separate survey indicates that patient willingness to participate in new trials has dramatically declined due to the pandemic.