Latest From Vibha Sharma
Global Medtech Guidance Tracker: May 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-seven documents have been posted on the tracker since its last update.
UK Aims To Quadruple Patient Recruitment To Industry Clinical Trials By 2027
The UK government has set aside dedicated funds to deliver ambitious changes that would make it quicker and easier for companies to trial more of their products in the National Health Service.
EMA To Explain How Trial Transparency & Data Redaction Can Live Together
The European Medicines Agency is working to align the redaction and data anonymization principles underpinning two EU clinical trial transparency initiatives to ensure consistency in disclosure requirements.
ICH Consults On Modernized GCP Principles To Make Clinical Trials More Efficient
The International Council for Harmonisation has issued updated Good Clinical Practice principles to accommodate new clinical trial and data types.
EMA Looks For Efficiencies For Companies Ahead Of Relaunching Clinical Data Transparency Policy
Based on its learnings from proactively publishing clinical trial data on COVID-19 products, the European Medicines Agency is making procedural changes to its clinical data publication policy that is set to resume after being temporarily suspended in 2018.
Updated EU CTIS Guide Offers Workaround To Protect ‘Commercially Confidential’ Dosing Data
EU regulators explain how sponsors who are running integrated Phase I/Phase II trials can overcome default transparency settings in the Clinical Trials Information System to protect the disclosure of dosing details if these contain commercially confidential information.