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 the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips for working with European regulators. The seminar covers the impending changes coming with the EU Parliament's 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 the 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 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 the 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 affect 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
European Filing & Registration Procedures
Cessing License Variations
EU Decision-Making Process
Review of Regulatory Authorities
Member State Analysis of Applicable Regulations At All Levels With Practical Examples of How the Regulations Are Applied
Political Implications of The Regulations
How and When to Influence the Regulatory Process
Speaker
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.Who Should Attend
- Business Management
- Project Team Members
- Legal Team Members
- Clinical Operations Staff
- Quality Assurance, Monitors, CRAs
- Regulatory Affairs
- Investigators & Site Study Staff
- CROs, Consultants, Insurers
