The European Clinical Trial Directive…Plus…European Filings and Registration Procedures: 2-day In-person Seminar

Course Description:

This interactive two day seminar will cover 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, 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.

This two day interactive course on European Clinical Trial Directive will cover:

• Requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive (for Drugs, Biologics & Combination Products);
• Recent updates on EU-GCP associated with the Directive;
• Highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators;
• Changes to the Clinical Trial Directive that are being contemplated and may receive modification.

Learning Objectives:

Attendees will leave the Course clearly understanding the requirements under the current Directive. This course is designed to provide an overview of the regulatory environment throughout Europe and will provide training in:

• How the EU and individual countries within Europe interact
• Which registration procedure to use
• How regulations effect product development strategies
• Pricing issues – Coordinated filing vs. Individual filing
• 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 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:

• Clinical Operations Staff
• Project Team Members
• Quality Assurance, Monitors, CRAs
• Regulatory Affairs Personnel
• Investigators & Site Study Staff
• Clinical Trial Supply
• CROs, Consultants, Insurers