HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Vibha Sharma

Senior Writer

London, UK
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

EU Guide Outlines Important Considerations For Submitting Complex Trials In CTIS

EU regulators have issued a new Q&A document on the key aspects that sponsors of complex trials should consider when making new submissions or moving ongoing studies to the Clinical Trials Information System.

Europe Clinical Trials

UK’s Revamped Clinical Trials Framework To Offer Faster Application Review Timelines Than EU

The UK has finalized plans for delivering what it believes will be a stable and streamlined clinical trials framework following its departure from the EU. Transparency, patient involvement and diversity are high on the agenda.

United Kingdom Clinical Trials

EU IVD Regulation Delaying Clinical Trials Using Diagnostics

The challenges posed by the implementation of the EU IVD Regulation are having a negative impact on medicine trials using diagnostics. Many such studies are currently stalled and research-based drug companies are calling on all partners to engage in dialog to find an urgent solution.

Clinical Trials Regulation

Pharma Blames EU IVD Regulation For Clinical Trial Delays

The challenges posed by the implementation of the EU IVD Regulation are having a negative impact on medicine trials using diagnostics. Many of such studies are currently stalled and research-based drug companies are calling on all partners to engage in dialog to find an urgent solution.

Clinical Trials Regulation

Global Regulators Outline Quality Expectations For Cell And Gene Therapy Raw Materials

The International Pharmaceutical Regulators Programme explains how manufacturers of cell and gene therapy products can assess and mitigate the potential risks associated with product raw materials.

International Gene Therapy

Patient Groups Back EU Cross Border Clinical Trials Access Initiative

An EU project for framing recommendations and best practices to improve cross-border access to clinical trials is gathering pace.

Europe Clinical Trials
See All
UsernamePublicRestriction

Register