The 2001 Clinical Trials Directive (2001/20/EC) has been criticised by patients, researchers and industry alike for its disproportionate regulatory requirements. High costs and a lack of harmonisation of the applicable rules necessary for multinational clinical trials have contributed to a significant decline in the number of clinical trials in the EU – a reduction of about 25% in the last few years.
The new EU Clinical Trials Regulation is due to be enacted in 2016 and will replace the 2001 Clinical Trials Directive (CTD) (2001/20/EC). The Regulation aims to restore the EU’s competitiveness in clinical research and the development of new and innovative treatments and medicines by cutting red-tape and bringing patient-oriented research back to Europe.
The regulation includes rules for clinical trials which are conducted outside the EU but referred to in a clinical trial application within the EU. For such trials, the rules call for compliance with regulatory requirements at least equivalent to those in the EU, including rules on transparency.
In this highly interactive course, we explore the changes proposed by the regulation and how they will impact our current practices in conducting global clinical trials.
• Distinguish between a Regulation and a Directive
• Identify what will change under Regulation 536/2014
• Identify what will not change under Regulation 536/2014
• Define Low-Impact Interventional Trials
• Discuss the impact on:
– Application processes
– Informed consent
– Transparency requirements
• Describe next steps for implementation of Regulation 536/2014
• Review of the current regulatory situation in EU
• Directive vs Regulation
• Clinical Trial Authorization Process
• Trials in Emergency Situations
• Trials with authorized medicinal products
• Risk Based Evaluations
• Non-EU Sponsors
• Insurance Issues
• Co-Sponsorship Concept
• Safety Reporting
• Inspections in EU and Beyond