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.

Agenda:-

New EU CT Regulation

• Overview of the EU and EU Regulatory Structure
• Overview of the previous EU Clinical Trial Directive
• Impending Changes of the EU Clinical Trial Regulation
• 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
  • Labeling Requirements
  • Fees
• End of a Clinical Trial
• How Changes of the new Clinical Trial Regulation will affect Sponsors

European Filing & Registration Procedures

• EU Agency Regulatory Structure
• Registration Options
• Company Strategy - Linking Clinical Trials & Marketing Authorization Applications
• Balancing Strategy and Long-Term Regulatory Cost & Maintenance
• Registration Procedures

Member State [National] Procedures

Mutual Recognition Procedure

Centralized Procedure

Generics, Orphan Drugs, Biologics and Combination Products

Cessing License Variations

Changes Concerning Manufacturing / Formulation Aspects (Product & Process)

• Labeling & Packaging Leaflet Requirements

EU Decision Making Process

• Scope
• Check-in Procedure
• Consultation
• Industry's Ability to Impact - Involvement & Timing
• Standing Committee Participation
• Favorable Standing Committee Opinion
• Non-Favorable Opinion - Process & Timing

Review of Regulatory Authorities

• International, Regional, and Local laws applicable for each European Union Nation

Member State Analysis of Applicable Regulations At All Levels With Practical Examples of How the Regulations Are Applied

• Legislative Process
• Objectives of the Rules Governing Medicinal Procedures
• Regulatory Framework
• New Products, Requirements, & Procedures

Political Implications of The Regulations

• Compare/Contrast EMA and the FDA procedures

How and When to Influence the Regulatory Process

• Effective Monitoring Activity
• Association vs. Individual Company Involvement & Intervention
• The Regulatory Negotiation Process
• Effective Approaches
• The Do's and Don'ts of Regulatory Involvement

Maintaining Your License: Renewals

Helpful Websites

Glossary of Terms

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