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

Saudi FDA Finalizes Approach To Commercial Info In Public Assessment Reports

Saudi Arabia has explained what information on a drug’s review will be made public following a marketing authorization decision. 

Saudi Arabia Guidance Documents

EU Finalizes Option To Omit Expiry Date On Inner Labeling Of Investigational Drugs

Revised labeling requirements for unauthorized investigational and auxiliary medicinal products under the EU Clinical Trial Regulation have been published in the Official Journal.

Europe Clinical Trials

EMA Launches First RWE Studies Under Big Data Project

The European Medicines Agency has partnered with eight institutions having access to real-world healthcare data to enable its DARWIN EU project to deliver real-world evidence to the EU medicines regulatory network when needed.

Europe Real-World Evidence

EU Refines Simultaneous Scientific Advice Pilot With Focus On Clinical Trials

Improvements have been made to the second phase of an EU pilot that allows drug sponsors to obtain simultaneous scientific advice from two member states.

Europe Clinical Trials

EMA, PIC/S To Update 11-Year-Old GMP Guide On Computerized Systems

The European Medicines Agency and the international association of pharmaceutical inspectorates, PIC/S, say they need to make extensive changes to their guide on using computerized systems when manufacturing medicines.

Europe International

EMA Consults On Need For New Guide To Enable Confirmatory Platform Trials

The European Medicines Agency believes that a scientific guideline on clinical trials incorporating a platform design is needed because such studies are expected to play an increasingly important role in future marketing authorization applications.

Europe Clinical Trials
See All
UsernamePublicRestriction

Register