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
European Union vs. The United States
Who Will Benefit:
Clinical Operations Staff
Project Team Members
Quality Assurance, Monitors, CRAs
Investigators & Site Study Staff
Clinical Trial Supply
CROs, Consultants, Insurers
Robert J. RussellRobert J. Russell For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.