Regulatory Compliance in Clinical Trials

• Regulations in clinical crials: basic knowledge for your work
• Patient and drug safety: guidelines, documentation, and reporting obligations
• Compliance for sponsors of clinical trials: quality & risk management, data integrity
• IMP compliance: responsibilities at the GCP/GMP interface

Who should attend

• require a compact compliance update on the essential regulations and requirements for their work in European clinical drug trials.
• wish to obtain proof of their qualifications.

To undertake a role in clinical drug trials, a comprehensive understanding of compliance, adherence to laws, regulations, and defined requirements is essential.

This 4-part webcast series provides you with a concise two-day knowledge update on all compliance requirements in clinical trials within the European scope.

Starting with the regulations that form the basis for all actions in clinical studies, you will learn about the requirements for patient and drug safety, as well as the responsibilities of sponsors in clinical trials. Data integrity, risk-based quality management, and collaboration with contract partners will also be covered, as will the correct handling of the investigational medicinal product itself.

Equipped with this knowledge, you will be able to carry out your work in clinical trials in Europe independently and in compliance with regulations.

A post-training examination ensures that the knowledge imparted is retained and readily applicable.

• Compact knowledge update: all requirements for your daily work in European clinical drug trials
• 4 Live webcast sessions over two days - perfectly integrated into your work schedule
• Exam and certificate - your qualification proof for audits and inspections