Vibha Sharma
Senior Writer
Latest From Vibha Sharma
Pakistan Explains Updated Risk-Based Criteria For GCP Inspections
Pakistan’s drug regulator is hoping that improved transparency on its inspection protocols will help research entities better prepare for good clinical practice inspections.
UK MHRA Inspector Highlights Mistakes Made In Decentralized Clinical Trials
Inadequate risk assessments, participant confidentiality breaches and issues with documenting and verifying clinical trial activities have emerged as recurring themes in inspections of decentralized clinical trials by the UK medicines regulator.
UK, US & Canada Regulators Explain Why Decentralized Trials May Get A Closer Look
Decentralized clinical trials are subject to the same regulatory requirements as traditional site-based trials, but are of special interest to regulators because they represent a new way of working.
Global Pharma Guidance Tracker – February 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Global Medtech Guidance Tracker: February 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
Singapore & South Korea’s Recognition Of GMP Inspections To Cut Burden For Companies
A new agreement signed between Singapore’s Health Sciences Authority and South Korea’s Ministry of Food and Drug Safety means drug manufacturers in the two regions will be subjected to fewer duplicative good manufacturing practice inspections.