Local Clinical Trial Legislation in the USA – eLearning
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| Date | Product | Location | Price | |
|---|---|---|---|---|
| Local Clinical Trial Legislation in the USA | eLearning | EUR 200.00 | Book | |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
Do you need a clear and hands-on understanding and be up to date with the most current national regulatory legislation for Clinical Trials with investigational medicinal products but also medical devices within the USA?This eLearning course will fulfil your expectations in a very practical way. It is an interactive approach to review and comprehend local regulations, and you can learn at your own pace.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule
- Course credit: 1,5h (3 months period to complete the course)
- Complete the course at any time, anywhere!
Course description
It is designed by local subject matter experts to always reflect the latest status of local legislation in the USA, both for medicinal products and medical devices. Interactive quizzes for self-assessment are included to provide a better understanding of the course.You will be able to test your comprehension with a final grading assessment.Programme highlight
- Legal Framework governing clinical trials with investigational medicinal products and medical devices
- Process, timelines, and fees for achieving clinical trial authorisation from the competent authorities
- Amendments & End of Trial Notification
- Safety Reporting
Learning objectives
- Get an overview of the local clinical trial legislation, for both medicinal products and medical devices
- Be able to identify and create legally required documents
- Know the procedures to be compliant and reach successful clinical trials submissions.
Who should attend
- Everyone involved in clinical research, including Pharmaceutical companies, Contract Research Organisations (CROs), Investigators, Site Personnel.
- People from clinical operations, regulatory affairs, quality assurance and pharmacovigilance departments are involved in monitoring activities (on-site or medical monitoring) of investigational sites.
- Everyone who wants to acquire knowledge of the Local Regulatory Requirements.
- Everyone needs to comply with local regulatory training requirements prior to performing work locally.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (1)
- Clinical Studies Operations (GCPs or ISO 14155) (2)
- Study and Site Management (0)
- Data Management and Informatics (0)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
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