Regulatory course
Clinical Trial Requirements: Understanding variations between Europe and the USA (US Edition)
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.
Dates and booking
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Who it’s for
Is this course for you?
Everyone involved in international clinical research (pharmaceutical companies, Contract Research Organisations (CROs), investigators, site personnel, ethics committee members, etc.)
People from clinical operations, project management, regulatory affairs and pharmacovigilance departments within the pharmaceutical industry.
What you’ll learn
About this course.
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.
Learning objectives
- Have an overview of European and American legislation in general and understand the regulatory submission process and documents necessary for Clinical Trials
- Comprehend the rules in Europe and in the USA with regards to the protection of human study participants and data, investigator’s obligations, and safety reporting in clinical trials
- Know when to use mandatory clinical trial forms and database entries and updates in Europe and in the USA
- Understand similarities and differences in the ethical considerations and clinical trial responsibilities in Europe and the USA.
Programme highlights
- Regulatory Framework in EU and in US
- Update on European Legislative requirements for Clinical Trials
- Application Submission Process and Timelines
- Institutional Review Boards/Independent Ethic Committees (21 CFR Part 56 - Institutional Review Boards - HIPAA and Informed consent)
- Protection of Study Participants (Rules on Subject Protection)
- Understanding Investigator Obligations (FDA Form 1572, Financial Disclosure Form)
- Safety Reporting rules and timelines
- Public Registration of Clinical Trial Protocols and Clinical Trial Results
- Regulatory Inspections
Your trainer
Your trainer.
Good to know
Questions about this course.
Can I book for several colleagues?
Yes. Choose the number of participants next to a date. For a group of 4 or more, an in-house session tailored to your SOPs may suit you better.
What if I need to cancel?
Cancelling more than 30 calendar days before the course is free of charge. Between 21 and 30 days before, 50% of the fee is due, and the full fee within 21 days. A €50 administration fee applies per cancellation. You can also send a colleague in your place by letting us know in writing.