Overview
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
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
Speaker Profile
Robert J. Russell is a Global Regulatory and CMC expert with 28 years of prior industry experience in international regulatory management and compliance, global business development and global supply chain management. Mr. Russell formerly held senior leadership positions, in these functional areas, at Dow Pharmaceuticals and Cordis-Dow Medical Devices.
His experience and knowledge span Healthcare Authority’s requirements and regulatory processes across Life Science products.
For the past 18 years, Bob has been President & CEO of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding Regulations affecting compliance and in conducting product registrations with their clients in more than 95 countries.
He holds a BS / MS in Chemistry."
