As a direct result of the outbreak of the coronavirus disease (COVID-19) and due to circumstances beyond our control, DIA has decided to postpone the Clinical Trial Regulation Info Day to 14 September.
DIA’s mission – to work across the healthcare continuum to ensure patients receive the therapies they need – is more essential than ever during times like these. DIA acknowledges the time and effort that has gone into planning and preparing for DIA’s Pharmacovigilance Strategies Workshop, and trusts that everyone will understand the need to respond to current, evolving health concerns in a responsible manner. These precautions are being taken to ensure the health and safety of our entire, global DIA family.
DIA is committed to exploring all possible avenues to provide a productive setting and a fulfilling meeting experience. We appreciate your patience as we work through any potential challenges.
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.
- 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
Who should attend?
This event is specifically targeted to colleagues in CEE countries:
- Regulatory agencies: assessors, reviewers, inspectors
- The pharmaceutical industry and contract research organisations, including:
- Regulatory affairs personnel in clinical research
- Professionals in charge of clinical trial strategy
- Regulatory intelligence and policy professionals
- Change managers for clinical trials business processes
- Clinical research professionals working with submission, data, information sharing
- Clinical safety professionals
- Clinical Trials Investigators and Patients' associations representatives
- Laboratory experts in clinical trials
Mihaela David • Director Regulatory Affairs
PSI CRO AG, Romania, Romania
Steffen Thirstrup, MD, PhD • Director, NDA Regulatory Advisory Board
NDA Advisory Services Ltd, United Kingdom
Radoslaw Sierpinski • Acting President
Medical Research Agency, Poland
Elke Stahl, PhD • CTFG Co-Chair; Clinical Trial Unit
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Massimiliano Sarra • CTFG Secretary
Italian Medicine Agency (AIFA), Italy