This 6-hour live virtual seminar gives a comprehensive and practical understanding of the EU Clinical Trial Regulation (EU CTR 536/2014) and how to manage filings, submissions, and regulatory processes effectively across the European Union. The regulation has introduced significant changes to how clinical trials are conducted, submitted, and approved across EU Member States.

Organizations must now align with EU CTR 536/2014, manage submissions under evolving expectations, ensure compliance with EU-GCP and pharmacovigilance standards, and coordinate effectively with European regulatory authorities. Without the right understanding, this can lead to inefficient submission processes, approval delays, and challenges in regulatory coordination.

Participants learn to navigate the EU regulatory framework; understand the roles of the EU Commission, EMA, and national authorities; select appropriate registration procedures (National, MRP, DCP, Centralized); prepare and manage accurate submissions through the Clinical Trials Information System (CTIS); align clinical trial strategy with regulatory expectations; and maintain GCP and pharmacovigilance compliance, including risk management under ICH Q9. Each registered attendee receives presentation slides, a certificate of participation, a Q&A session, and free handouts.

Agenda at a glance:

• Session 1 — EU Regulation 536/2014 on clinical trials: foundations of science-based trials, clinical trial basics, and trial subjects’ concerns and rights.
• Session 2 — ICH Q7, API cGMPs and QMS: required records and methods validation.
• Session 3 — Risk management in EU new drug development: ICH Q9, the Risk Management File, hazards list, FTA, and D-/P-/U-FME[C]As.
• Session 4 — Investigational Medicinal Products (IMPs) and EU medicinal product requirements.
• Session 5 — EU clinical trials application process: AMS, CMS, and required documents; review and Q&A.

After this webinar, attendees will be able to answer -

• How does EU CTR 536/2014 change the way clinical trials are submitted and approved across Member States?
• How do the EU Commission, EMA, and national authorities each contribute to the regulatory framework?
• Which registration procedure — National, MRP, DCP, or Centralized — is appropriate, and why?
• How are accurate, efficient submissions prepared and managed through CTIS?
• How does risk management under ICH Q9 fit into EU new drug development?
• How do you maintain GCP and pharmacovigilance compliance and keep documentation audit-ready?

This webinar benefits the following agencies -

The session is built around the EU Clinical Trial Regulation (EU CTR 536/2014) and the CTIS submission system, referencing the roles of the EU Commission, EMA, and national authorities, along with ICH Q7 and ICH Q9. It is relevant to organizations conducting clinical trials across the European Union.

Who should attend?

This seminar benefits professionals involved in EU clinical trials, including:

• Business Management and Project Team Members
• Legal Team Members
• Clinical Operations Staff
• Quality Assurance, Monitors, and CRAs
• Regulatory Affairs Professionals
• Investigators and Site Study Staff
• CROs, Consultants, and Insurers