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
The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including three orphans. A decision is also due on a previously-rejected Alzheimer’s drug that was under re-examination.
The European Medicines Agency wants to develop a structured framework for non-clinical proof-of-concept studies in pediatric oncology.
The first multinational clinical trial approval under the EU’s 70‑day fast-track pilot pathway is expected by the end of April 2026.
The European Medicines Agency has requested updated safety warnings for Ixchiq’s product information after a case of aseptic meningitis was reported in a healthy young adult.
Denmark’s medicines regulator has published guidance to support the progression of investigational advanced therapy medicinal products into first-in-human trials by clarifying the expectations for preparing investigator’s brochures.
EU data protection bodies back clinical trial harmonization under the draft Biotech Act, but insist on strong safeguards for sensitive health data.