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 the 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

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.
•  CROs, Consultants, and Insurers: Understand regulatory expectations, trial oversight, and risk management strategies for clinical trials.