6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & RegistrationsSeptember 22, 2021 - CA US
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 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 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 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.