This Clinical Trial Regulation Information Day provides a forum to prepare stakeholders from Central and Eastern European Countries for the implementation and launch of the new EU Clinical Trial Regulation (536/2014) which will replace the European Clinical Trials Directive (2001/20/EC). The Information Day will focus on the differences between the present and new requirements for managing clinical trials in the face of forthcoming changes. It further aims to provide a platform for discussion about the compliance with the new Regulation and associated implementing acts in the region. You will hear from experts in the field and regulators from various Member States about their preparedness status for the new legislation and how the new rules will impact clinical trials run in the EU.

Featured topics

• Clinical Trials Regulation objectives and why the replacement of EU Directive is needed
• Clinical Trial Regulation Overview and Latest Status
• Key changes from Directive to Regulation and associated challenges
• Procedure for Initial Authorization and Substantial Modifications Mono and Multinational CTs
• Submission of application dossier  
• Part I common scientific documents
• Part II the national documents
• New Process for Clinical Trial Registration and EU CT number application
• Transition from the Directive to the Regulation
• Implementation and readiness status at the local level in Central and Easter European countries
• Competent authorities and Ethics Committees perspectives
• Update on the CT Information System (CTIS) formally “EU Portal and Database”
• Clinical Trials Regulation related guidelines

Program Committee