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The European Clinical Trial Directive…Plus…European Filings and Registration Procedures

By:
Robert J. Russell, President of RJR Consulting, Inc.
Coming soon.. Please contact customer care for new schedule

Course "The European Clinical Trial Directive…Plus…European Filings and Registration Procedures" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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


Areas Covered in the Seminar:

  • Overview of the EU and EU Regulatory Structure
  • Overview of the EU Clinical Trial Directive and the 2007 Pediatric legislation
  • Marketing Authorization Options in the EU
    • Mutual Procedure
    • Decentralized Procedure
    • Centralized Procedure
  • Common Technical Document
  • Clinical Trials in the EU
    • Phases of a clinical trial
    • Start Up and Application Processes
    • Ethics Committee and Competent Authority Review Process
    • Trial Protocol and Management
    • GCP and GMP Compliance
    • Fees
  • End of a Clinical Trial
  • Variations, Renewals and Changes to Marketing Authorizations and Clinical Trial Applications
  • Generics, Orphan Drugs, Biologics and Combination Products
  • Overview of the New Pharmacovigilance Directive and Regulations
  • European Union vs. The United States
  • Navigating the Regulatory Process
  • How the EUCTD Affected CROs
  • Update to the Directive
  • Current Events
  • Appendix
    • EU Healthcare Authorities
    • Abbreviations Glossary


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




Course Outline:

Day One (8:30 AM - 4:30 PM) Day Two (8:30 AM - 4:30 PM)

Registration Process: 8:30 AM - 9:00 AM

Session Start Time: 9:00 AM

Overview of the European Union

Regulatory Overview of the EU

  • Government Agencies
  • European Medicines Agency
    • Scientific Committees
    • Working Groups

The EU Clinical Trial Directive

  • Development of the EUCTD
  • What is in the EUCTD
  • Goals of the EUCTD
  • 2007 Paediatric Legislation
    • Objective of the Paediatric Legislation
    • Paediatric Committee
    • Paediatric Investigation Plan (PIP)

Marketing Authorization Options in the EU

  • Mutual Recognition
  • Decentralized Recognition Procedure
  • Centralized Procedure

Common Technical Document

  • What is it?
  • Overview of the CTD structure
  • eCTD

Clinical Trials in the EU

  • Phases of a clinical trial
  • Trial Startup and Application Process
  • The Ethics Committee
  • The Competent Authority
  • Trial Protocol and Management
  • Investigational Medicinal Product Dossier
  • Good Clinical Practice
    • Commission Directive
    • GCP Guidelines
    • GCP Inspections
  • Good Manufacturing Practice
    • Commission Directive
    • GMP Guidelines
    • GMP Inspections
  • End of a Clinical Trial

    Pharmacovigilance
    • What is it?
    • The new Pharmacovigilance Regulations and Directives
      • GVP Modules
      • How legislation will improve patient safety
      • Legislation’s affect of Marketing Authorization Holders
      • Adverse Reaction Reporting
      • Labeling Changes
      • Pharmacovigilance Risk Assessment Committee
    • Guidelines on GVP Modules
      • GVP Modules I-XVI
    • Generics
    • Orphan Drugs
    • Biologics
    • Combination Products
    • Variations
    • Stability Studies
    • Advertising
    • Fees
    • Marketing Authorization Holders Responsibilities
      • Maintaining your license
      • Renewals
    • US vs EU
      • Differences within the EU Member States
        • Sweden
        • Finland
        • UK
      • United States
    • Navigating the Regulatory Process
    • How the Directive affected CROs
    • Updates to the Directive
    • Current Events in the EU





Meet Your Instructor

Robert J. Russell
President of RJR Consulting, Inc

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc., a Global Regulatory Consulting company, specializing in understanding regulatory issues for the pharmaceutical, medical device and combination products industry. Bob has more than 30 years of experience working with FDA, EMA, Healthcare Authorities and Agencies across Latin America, Middle East and Asia / Pacific supporting clients projects in these regions. Licensing, registrations, GMP, DMFs and borderline products are core competencies of the Course Director.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 manufacturers of Drugs and Medical Devices. RJR's offices are located in every major region with in-country experts on staff handling local regulatory needs. Bob has a BS and MS in Chemistry.





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