Vibha Sharma
Senior Writer

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.
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.
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.
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.”
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.
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.