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.
This EU Clinical Trial Regulation (EU CTR) 536/2014 training provides a comprehensive understanding of the requirements for conducting clinical studies across the European Union, covering both drugs and biologics. Participants will gain up-to-date knowledge of EU-GCP standards aligned with the new regulatory framework and learn about the EU Pharmacovigilance Directive as it relates to safety reporting, inspections, and collaboration with European regulators.
The course highlights the key changes introduced by the EU Clinical Trial Regulation, impacting all new and ongoing trials across EU Member States. It also explains licensing procedures for drugs, biologics, and combination products, including how to obtain Marketing Authorizations through national, mutual recognition, decentralized, and centralized procedures within the EU and EEA.
Attendees will explore the structure and functions of EU regulatory agencies, understand the application and review processes under each pathway, and gain practical insights into managing submissions efficiently. This program is ideal for professionals seeking to navigate EU CTR 536/2014 compliance, optimize CTIS submissions, and stay ahead of evolving clinical trial and pharmacovigilance regulations.
This EU Clinical Trial Regulation (EU CTR) 536/2014 training provides a comprehensive understanding of the requirements for conducting clinical studies across the European Union, covering both drugs and biologics. Participants will gain up-to-date knowledge of EU-GCP standards aligned with the new regulatory framework and learn about the EU Pharmacovigilance Directive as it relates to safety reporting, inspections, and collaboration with European regulators.
The course highlights the key changes introduced by the EU Clinical Trial Regulation, impacting all new and ongoing trials across EU Member States. It also explains licensing procedures for drugs, biologics, and combination products, including how to obtain Marketing Authorizations through national, mutual recognition, decentralized, and centralized procedures within the EU and EEA.
Attendees will explore the structure and functions of EU regulatory agencies, understand the application and review processes under each pathway, and gain practical insights into managing submissions efficiently. This program is ideal for professionals seeking to navigate EU CTR 536/2014 compliance, optimize CTIS submissions, and stay ahead of evolving clinical trial and pharmacovigilance regulations.
Course Content
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
- ICH Q7 API CGMP
- Additional CGMP considerations
- Required Records
- Methods Validation
- Break
- ICH Q9
- Risk Management File - Narrative
- Hazards List, FTA, D-, P-, U-FME[C]A’s
- Review / Report; Use
- EU Medicinal Products Requirements
- IMPs
- Application Process
- AMS, CMS
- Required documents.
- Review
- Q&A
- Note: Times are approximate.
Course Provider
John E. Lincoln,
Who Should Attend
- Business Management: Gain insights into regulatory compliance and operational implications of EU CTR 536/2014 for strategic decision-making.
- Project Team Members: Understand trial planning, documentation, and cross-functional responsibilities to ensure smooth execution.
- Legal Team Members: Learn regulatory and legal requirements, risk mitigation, and compliance considerations for clinical trials.
- Clinical Operations Staff: Acquire practical knowledge on trial conduct, submission processes, and documentation under EU CTR.
- Quality Assurance, Monitors, CRAs: Understand inspection readiness, audit preparation, and quality control requirements.
- Regulatory Affairs Professionals: Master CTR application submissions, safety reporting, and regulatory alignment across member states.
- Investigators & Site Study Staff: Gain awareness of protocol compliance, reporting obligations, and essential document management.
- CROs, Consultants, and Insurers: Understand regulatory expectations, trial oversight, and risk management strategies for clinical trials.
