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.
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
6.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 6.0 credits towards a participant's RAC recertification upon full completion.
Course Content
Course Provider
John E. Lincoln,
Principal Consultant ,
J. E. Lincoln and Associates LLCJohn E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company, with over 33 years’ experience in U.S. FDA-regulated industries and 20 years as a full-time consultant. He has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.
He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process/ product/ equipment including QMS and so+E6ftware validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects. 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
