Welcome to our specialized two-day training course focused on "Handling of Serious Breaches in Clinical Trials: Auditors' Insights." As the clinical research landscape adapts to the implementation of EU Regulation 536/2014, effective since 2022, the need for proficient handling of serious breaches has become more critical. The European Medicines Agency (EMA) has laid down detailed guidelines for the notification of serious breaches of this regulation or the clinical trial protocol. However, audits and inspections continue to reveal significant gaps in how companies, including Sponsors and Contract Research Organizations, identify and report these serious breaches.

These challenges are not limited to identification and reporting. The industry still faces hurdles in conducting thorough investigations, performing appropriate root cause analyses, and developing and successfully implementing Corrective

and Preventive Actions (CAPA). Addressing these issues is vital for the integrity and success of clinical trials.

Our seasoned team of Quality Assurance professionals will provide deep insights into these complex issues. The course is tailored to address the varying guidelines and regulations across regions related to the management of serious breaches.

This training is essential for all clinical research professionals responsible for managing noncompliance and serious breaches, particularly those involved in the development, execution, and follow-up of CAPA. Our goal is to empower attendees with the knowledge and skills needed to effectively handle serious breaches, enhancing the quality and reliability of clinical trials.

Join us in this critical exploration to gain a deeper understanding and enhance your expertise in managing serious breaches in clinical trials, guided by the insights of experienced auditors.