Six top tips to prepare for the new EU Clinical Trial Regulation
The European Union Clinical Trial Regulation 536/2014 (EU-CTR) aims to standardize and harmonize the conduct and management of interventional clinical trials across the European Economic Area (EEA), with legally binding rules on requirements and increased transparency. The new EU-CTR promises a simplified process designed to decrease the burden resulting from idiosyncratic interpretations of the current EU-CTD. But to reap efficiencies, sponsors must sow operational changes. This article covers the six essential preparations companies should undertake now.
Related Insights
Blog
Adoption of the ICH Q12 guideline: New Horizons for Efficient Product Supply Chain Management for a Key Global Market
Nov 13, 2023
Article
Near-term strategies for biotech drug developers facing shifting healthcare dynamics
Feb 14, 2024
Article
Expedited Pathways Comparisons - US EU CHN
Oct 19, 2021
Article
Australia: The Regulatory and Reimbursement Environment
Aug 28, 2023
Blog
Ensuring future success in a new market by delivering a robust safety database solution
Aug 4, 2023
Webinar
Assessing appropriate use of ECAs in clinical trials
May 28, 2023
Article
The technologies that are reshaping biotherapeutics manufacturing, an EU perspective
Jul 6, 2023
Whitepaper
How to prepare for Policy 0070: Challenges and opportunities for clinical data publication in the EU
Jun 28, 2023
Blog
Population variability: important considerations in vaccine development
Jun 14, 2023
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Jun 6, 2023
Webinar
Accelerate global drug development: Leveraging China regulatory changes
Aug 15, 2025
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Related Insights
Blog
Adoption of the ICH Q12 guideline: New Horizons for Efficient Product Supply Chain Management for a Key Global Market
Nov 13, 2023
Article
Near-term strategies for biotech drug developers facing shifting healthcare dynamics
Feb 14, 2024
Article
Expedited Pathways Comparisons - US EU CHN
Oct 19, 2021
Article
Australia: The Regulatory and Reimbursement Environment
Aug 28, 2023
Blog
Ensuring future success in a new market by delivering a robust safety database solution
Aug 4, 2023
Webinar
Assessing appropriate use of ECAs in clinical trials
May 28, 2023
Article
The technologies that are reshaping biotherapeutics manufacturing, an EU perspective
Jul 6, 2023
Whitepaper
How to prepare for Policy 0070: Challenges and opportunities for clinical data publication in the EU
Jun 28, 2023
Blog
Population variability: important considerations in vaccine development
Jun 14, 2023
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Jun 6, 2023
Webinar
Accelerate global drug development: Leveraging China regulatory changes
Aug 15, 2025
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023