The European Clinical Trial Directive (EUCTD)
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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.
Additionally, changes to the Clinical Trial Directive are being contemplated and the Course Director will provide insight into those areas, which may receive modification.
Learning Objectives: Attendees will leave the Course clearly understanding the requirements under the current Directive. In addition, this Course has been updated to provide participants with competitive insight into:
Areas Covered in the Session:
- How to efficiently initiate trials
- 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
- EUCTD vs. FDA Regulations
Who Will Benefit:
- Overview of the EU and the EU Regulatory Structure
- Marketing Authorization Options in the EU
- Overview of the European Union Clinical Trial Directive
- 2007 Pediatric Legislation
- 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
- Good Manufacturing Practice
- Handling the end of Clinical Trial
- Clinical Trial Databases
- European Union vs. The United States
- Regulatory Process in the EU
- Recent updates to the Directive
- Clinical Operations Staff
- Project Team Members
- Quality Assurance, Monitors, CRAs
- Regulatory Affairs
- Investigators & Site Study Staff
- Clinical Trial Supply
- CROs, Consultants, Insurers
Robert J. Russell is a Global Regulatory and CMC expert with 28 years of prior industry experience in international regulatory management and compliance, global business development and global supply chain management. Mr. Russell formerly held senior leadership positions, in these functional areas, at Dow Pharmaceuticals and Cordis-Dow Medical Devices.
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."