Clinical Trial Requirements: Understanding variations between Europe and the USA (US Edition)

Reasons to attend

Clinical research is increasingly globalized.  Advances in technology and science have mandated revised harmonization guidelines and updated regulations and legislation in both the United States of America and the European Union.  Do you want to better understand the drug development process to provide a more comprehensive understanding of the ethical and regulatory differences between these two regions? We invite you to attend this course and learn about the similarities and differences in clinical research between Europe and the United States.   Join us as we review the legal framework, ethical considerations and reporting requirements that ensure participant protection, confidentiality and data integrity across the world.

What's included?

• Documents and materials related to this course are included
• Globally recognised certificates awarded after test completion

Course time

• 1 day from 9am to 4pm OR
• 2 webinars of 3 hours

Course description

This course is designed for personnel involved in conducting clinical trials under the authority of the US Department of Health and Human Services Food and Drug Administration (FDA) or under the European Commission (EC) and European Medicines Agency (EMA) who want to understand the differences and similarities in the research process to foster a robust understanding of global clinical trials. Information is focused on fundamental topics in Europe and in the USA and highlight the different procedures, documents and guidelines.

This course will provide a valuable refresher for those well versed in global regulations and ethical guidelines and provides an abundance of knowledge for those striving for a more comprehensive understanding including specific forms required by competent authorities and details from the Code of Federal Regulations (CFR) and Regulation (EU) No 536/2014 (Clinical Trials Regulation).  Topics also include investigator commitments, participant protection and safety reporting.

Interactive quizzes and exercises for self-assessment are included to provide a better understanding of the course.