Regulatory course
Basics on Regulatory Requirements in Clinical Researc- eLearning
Basic understanding of the current regulatory requirements for Clinical Trials for people who have limited or no background in these matters.
Dates and booking
Choose your date.
All fees exclude VAT. Booking for several colleagues? Choose the number of participants, or ask about an in-house session.
Who it’s for
Is this course for you?
People starting in the clinical research field in operational roles as well as people in other domains, who want to have a clear and basic understanding of clinical trial rules.
What you’ll learn
About this course.
Learning objectives
- Understand the basic concepts of and obtain a clear view on the clinical research regulations and how they came to existence
- Be able to identify what is needed in order to get the required approvals to start a clinical study
- Get familiar with terminology and abbreviations
Programme highlights
- Clinical trials
- Why & When
- Difference with regular medical practice
- Rules for clinical research:
- History (tragic mistakes)
- Declaration of Helsinki
- ICH-Good Clinical Practice
- Legal framework
- Definitions and frequently used abbreviations (plus exercise)
- Getting the approval for starting a clinical trial
- Process
- Documents
Format
How the course runs.
eLearning
Online, at your own pace.
Competencies
What this course builds.
How many competencies of the ECCRT Competency Framework this course covers, by area.
- Investigational Product Development and Regulation6
- Ethical & Participants Safety Considerations2
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.
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