Master EU CTR 536/2014 Compliance Implementation with Confidence
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.
Learning Objectives
By the end of this EU Clinical Trial Regulation (EU CTR) 536/2014 Compliance & Implementation Training, attendees will gain a clear and practical understanding of the current EU regulatory requirements governing clinical trials, drug development, and product registration across Member States.
This updated course provides participants with competitive insights into critical topics such as:
- How the EU Commission, EMA, and national authorities interact within the regulatory framework
- Choosing the right registration procedure (National, MRP, DCP, or Centralized)
- How evolving EU regulations impact product development strategies
- Key concerns and expectations of European regulatory personnel
- Proven approaches for effective communication and negotiation with regulators
- Information essential for accurate and efficient regulatory submissions
- Strategies to streamline registration applications for faster market approval
- Understanding the advantages and disadvantages of each EU registration route
- How to initiate clinical trials efficiently — from first patient to first visit
- Linking country selection strategy to the optimal EU marketing authorization pathway
- Staying GCP and Pharmacovigilance (PV) compliant under the new framework
- Preparing for impending changes and implementation timelines of the EU CTR 536/2014
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: 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.
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CROs, Consultants, and Insurers: Understand regulatory expectations, trial oversight, and risk management strategies for clinical trials.
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.
Hear from Our Learners: Real Success Stories
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“This course gave me a clear understanding of EU CTR 536/2014 requirements. The practical examples and templates have helped our team streamline multi-country clinical trials.”
— Clinical Operations Manager
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“I now feel confident preparing trial documentation, safety reports, and regulatory submissions under the EU Clinical Trial Regulation. Highly practical and relevant.”
— Regulatory Affairs Specialist
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“A must-attend course for anyone involved in clinical trial management across Europe. The best practices shared are directly applicable to our ongoing studies.”
— Project Manager, Clinical Trials
✅ Frequently Asked Questions (FAQ)
1. What is the focus of this course?
This training focuses on EU Clinical Trial Regulation (CTR) 536/2014, guiding participants on compliance, implementation, trial documentation, safety reporting, and best practices for multi-country clinical trials.
2. Is prior experience required?
No formal experience is required, though familiarity with clinical trial processes or regulatory affairs will help maximize learning.
3. Can this training help with inspections or audits?
Absolutely. Participants gain knowledge and practical tools to ensure trial documentation and processes are audit-ready and compliant with EU CTR 536/2014.
John E. Lincoln – Principal Consultant, J.E. Lincoln & Associates LLC
John E. Lincoln is the Principal of J.E. Lincoln & Associates LLC, bringing over 36 years of experience in FDA-regulated industries, including 22 years as an independent consultant. He has successfully partnered with organizations ranging from startups to Fortune 100 companies across the U.S., Mexico, Canada, France, Germany, Sweden, China, and Taiwan.
John specializes in Quality Management Systems (QMS), regulatory compliance, and FDA remediation strategies. His expertise spans 510(k) submissions, Design Control and Design History Files, ISO 14971 risk management, CAPA systems, process, product, and software validation, and technical documentation.
As a recognized industry expert, John helps medical device and life science companies ensure FDA, ISO, and global regulatory compliance through practical, risk-based quality and validation solutions.
