The New European Clinical Trial Regulation
This course covers the newly proposed requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation 536/2014 (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators.
This NEW REGULATION will affect ALL Sponsors of Clinical Studies conducted in the EU. Changes against the current EU Clinical Trial Directive 2001/20/EC are highlighted. This new regulation is expected to go into Force in the EU no earlier than May 2016. Knowing what changes will be implemented now, will allow all Sponsors time to adjust their processes and responsibilities across the EU.
Learning Objectives / Key Topics: Attendees will leave the Course clearly understanding the New Processes and Requirements for EU Sponsors of Clinical Trials as the New Regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission. In addition, this Course has been updated to provide participants with competitive insight into:
- How to efficiently initiate trials…..first patient, first visit.
- How to link the strategy of Country Selection to an ultimate EU Licensing Plan.
- Efficiently implementing studies via project teams and CROs at the National and multi-state level.
- How to stay compliant…..What can make the difference in your data passing Regulatory scrutiny.
- Related area-GCP and PV-reporting updates
- New EUCT Regulation vs. FDA Regulations
Areas Covered in the Session:
- Overview of the EU and the EU Regulatory Structure
- Marketing Authorization Options in the EU and Linkage to Conducting Clinical Studies
- Overview of the European Union Clinical Trial Regulation 536/2014
- Pertinent, Critical Articles of Regulation 536/2014
- Processes and Timelines
- The Ethics Committee
- Phases of a Clinical Trial
- Trial Protocol and Project Management
- Investigational Medicinal Product Dossier
- Standard Operating Procedures
- Clinical Trial Authorization Application
- Good Clinical Practice (GCP)
- Good Manufacturing Practice (GMP)
- Pharmacovigilance - New EU Requirements Overview
- End of a Clinical Trial
- Databases
- European Union vs. The United States
- Regulatory Process
- Questions
Who Will Benefit:
- Clinical Operations Staff
- Project Team Members
- Quality Assurance, Monitors, CRAs
- Regulatory Affairs
- Investigators & Site Study Staff
- Clinical Trial Supply
- CROs, Consultants, Insurers
His experience and knowledge span Healthcare Authority's requirements and regulatory processes across Life Science products. For the past 18 years, Bob has been President & CEO of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding Regulations affecting compliance and in conducting product registrations with their clients in more than 95 countries. He holds a BS / MS in Chemistry."