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.
Latest from Vibha Sharma
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 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.
As drug companies continue to explore the use of social media data to support their submissions, a panel of EU regulators have drawn up a seven-point action plan to help evaluate the usefulness and impact of such data in regulatory decision-making.
The International Council for Harmonisation has issued for comment draft guidance, which when finalized, is expected to provide the industry with flexibility to embrace non-traditional, innovative approaches in clinical trial design.
The European Medicines Agency wants to discourage drug companies from submitting marketing applications with very interim data cuts and then expecting they can supplement their application with more data later on by requesting for extended clock-stops.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.