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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Scientific advances in pharmacogenomics have prompted the European Medicines Agency to propose revisions to its existing guideline to ensure its continued relevance and applicability.
The EU is finetuning a new coordinated procedure to streamline the evaluation of multinational clinical trials and address persistent delays and inconsistencies in approval timelines under the Clinical Trials Regulation.
The growing use of non-clinical biomarkers in clinical trials of drugs for Parkinson’s disease has led the European Medicines Agency to propose changes to its guideline to clarify their role in patient enrollment for both targeted and non-targeted treatments.
The Association of the British Pharmaceutical Industry said 2024 marks the fourth consecutive year of declining patient recruitment in UK industry trials, calling it the most concerning trend despite a surge in trial initiations.
Integrating patient choice in clinical trials is a compelling vision, but achieving it at scale requires balancing flexibility with regulatory compliance, operational feasibility, and data integrity.