2019 - The EU Clinical Trial Regulation - EU Filings & Registrations

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics). The course also covers recent updates on EU-GCP associated with the new regulatory framework and highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. The webinar covers the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing].
This course also covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States [and EEA], as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.
Learning Objectives
Attendees will leave the Course clearly understanding the requirements under the current Regulations. In addition, this Course has been updated to provide participants with competitive insight into:
How the EU and individual countries within Europe interact
Which registration procedure to use
How regulations effect product development strategies
Understanding the concerns/issues of European Regulatory Personnel
How to negotiate with the regulators
Information necessary for effective submissions
Strategies for streamlining the registration application process for faster approval
The advantages and disadvantages of various registration procedures
How to efficiently initiate trials first patient, first visit
How to link the strategy of Country Selection to an ultimate EU registration pathway
How to stay compliant What can make the difference in your data passing Regulatory scrutiny
Related area-GCP and PV-reporting updates
Impending Changes of the EU Clinical Trial Regulation and timing for Implementation
Who Will Benefit
Business Management
Project Team Members
Legal Team Members
Clinical Operations Staff
Quality Assurance, Monitors, CRAs
Regulatory Affairs
Investigators & Site Study Staff
CROs, Consultants, Insurers