Vibha is a senior writer covering pharmaceutical and medtech regulatory developments across the globe. She plays a key role in tracking and writing about news of important regulatory issues affecting the sectors, and explaining their implications for industry. Vibha's fields of interest include the EU regulations on clinical trials, pharmacovigilance and pediatrics, 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.
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The UK’s proposed approach to recording informed consent for lower-risk trials is designed to ensure that patients still receive the critical information they need to consider participation, but are supported to give their consent in an easier way.
As the consultation period draws to a close for the UK’s new inclusion and diversity guidance, researchers and sponsors are being invited to participate in a pilot next year to submit a diversity plan as part of their clinical trial application.
As the consultation period draws to a close for the UK’s new inclusion and diversity guidance, researchers and sponsors are being invited to participate in a pilot next year to submit a diversity plan as part of their clinical trial application.
The International Coalition of Medicines Regulatory Authorities wants to see the rapid establishment and efficient conduct of platform clinical trials during public health emergencies.
The International Council for Harmonisation is seeking input from IT vendors on what it will take to establish a state-of-the-art technology platform that drug sponsors can use to submit quality-related post authorization submissions for collaborative assessment by multiple regulatory authorities.