Implementation Experience 2024 - EU (European Union) Clinical Trial Regulation: Overview and Implementation Experience Training Course

EU Clinical Trial Regulation Course Description
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
This live training Seminar includes the following for each registered attendee:
A copy of the presentation slides by download
A certificate of participation for attendee training records
Q/A Session
Free Handouts on EU Clinical Trial Regulation
How to Attend:
All WCS Seminar live training programs audio and visuals are delivered via Go to Webinar with a basic system requirement of a computer with internet access. You do not require a Go to Webinar account to join WCS Seminars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.