Pink Sheet 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 Advances Plans For New Catalogs Of RWD Sources & Non-Interventional Studies

Users of the new catalogs will benefit from a modern technology with enhanced view, search, export and data submission functionalities, says the European Commission.

Europe Real-World Evidence

WHO Seeks Feedback On Gaps In Current QA & GMP Guidelines

The World Health Organization has shortlisted over 30 quality assurance and good manufacturing practice guidelines that are over seven years old or need a major review.

International Guidance Documents

UK Phases In New Standards On Information Materials For Potential Study Participants

The Health Research Authority has developed UK-wide Quality Standards and Design and Review Principles to improve the information given to people who are invited to take part in research. Their use will become mandatory in December.

United Kingdom Clinical Trials

EU Group Facilitates Switching Multinational Trials To CTR

Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution oriented.”

Europe Clinical Trials

EMA Addresses Rapid Acting Therapies, Psychedelics In Updated Guidance On Depression Treatments

The European Medicines Agency is consulting on major changes to its decade-old guidance on the development of medicinal products for acute and long-term treatment of major depressive disorder.

Guidance Documents Regulation

UK MHRA Gets A Grip On Spiralling Clinical Trial Assessment Timelines

The UK medicines regulator says the loss of experienced staff and the need to recruit and train new assessors resulted in temporary delays to clinical trial applications, but the crisis measures it put in place to address the situation mean it has now turned the corner.

United Kingdom Clinical Trials
See All
UsernamePublicRestriction

Register