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

Stakeholders Weigh In On UK’s Clinical Trials Diversity Draft

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.

UK's Clinical Trials Diversity Draft Gets Over 200 Stakeholder Responses

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.

Global Regulators Explore The Opportunities & Challenges Involved With Platform Trials

The International Coalition of Medicines Regulatory Authorities wants to see the rapid establishment and efficient conduct of platform clinical trials during public health emergencies.

Plan For Global CMC Assessment Platform Advances To Next Phase

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.

EU Regulators Eye Social Media For Real-World Data Insights

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.

ICH Embraces Innovation In Clinical Trial Design

The International Council for Harmonisation has issued for comment draft guidance, which when finalized, is expected to provide the industry with flexibility to embrace non-traditional, innovative approaches in clinical trial design.