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 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
Agenda
Session 1: EU’s New Regulation 535/2014 on Clinical Trials, 2022 (77 slides)
- Introduction – Foundation of Science-based Clinical Trials
- Clinical Trial Basics
- EU Regulation 536/2014, recently implemented
- Trial subjects’ concerns / rights
Break
Session 2: ICH Q7, API CGMPs and QMS (81 slides)
- ICH Q7 API CGMP
- Additional CGMP considerations
- Required Records
- Methods Validation
Break
Session 3: Risk Management in EU New Drug Development (53 slides)
- ICH Q9
- Risk Management File - Narrative
- Hazards List, FTA, D-, P-, U-FME[C]A’s
- Review / Report; Use
Session 4: Investigational Medicinal Products (IMPs) (22 slides)
- EU Medicinal Products Requirements
- IMPs
Session 5: EU Clinical Trials Application Process (36 slides)
- Application Process
- AMS, CMS
- Required documents.
Review
Q & A
Note: Times are approximate.
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
Faculty John E. Lincoln
Principal of J. E. Lincoln and Associates LLC
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John 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 QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.
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.
World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria
