NEWS | Important Update for Clinical Trial Sponsors
The transition period for the EU Regulation on Clinical Trials on medicinal products for human use (CTR,
October 3, 2024
The transition period for the EU Regulation on Clinical Trials on medicinal products for human use (CTR,
The MHRA has issued a new guidance on the implementation of the Windsor Framework. This new guidance
The pharmaceutical industry is moving towards greater transparency, driven by requirements of regulatory authorities like the EMA and Health Canada.
Test your Regulatory knowledge!! The summer is back and, for a 4th year in a row, so
The European Commission is currently reviewing the procedures for post-authorisation changes to the terms of a marketing
CTIS is the single-entry point for the submission and assessment of clinical trial applications in the EU. It features a public, searchable database aimed at delivering a high level of transparency. The authorisation and oversight of clinical trials are managed by EU/EEA Member States, while the EMA maintains the CTIS. The European Commission oversees the implementation of the Clinical Trials Regulation.
Welcome to Asphalion Knowledge Centre, a training platform for Biotech, Pharma and MedTech professionals. Our platform offers specialized courses taught by expert trainers familiar with EU and US regulations, ensuring a relevant learning experience.
Search or filter
Services
Memberships & Partnerships
Quality Management System
SDGs
As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
© Asphalion
Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts.
We will be happy to assist you!
