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This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and European GCP requirements. The course aims to provide an overview and practical advice on the application and implementation of international accepted principles for GCP and clinical research.
Anyone involved in Clinical Research and Management
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
per participant (excl. VAT)
✓ Exclusive learning approach
✓ Personal course documentation
✓ Lunch, water, coffee & tea
✓ Course certificate after completion
Quastion Learning Center (Qplus consult BVBA)
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
Introduction to ICH-GCP
Why ICH-GCP guidelines were established
Clinical development program
Clinical Trial Protocol
What does it all contain?
Which requirements to follow
Sponsor and Investigator
How to choose
Informed Consent: what's in a name?
How to recruit?
Conduct and Monitoring
Data handling: is it easy or not?
What needs to be monitored?
Who will monitor?
What's the difference between an Adverse Event and an Adverse Drug Reaction?
How to report safety data
What, where and when?
Is it time to closure?
Result Analyses and Interpretation
How to obtain a Clinical Study Report
Communication of Trial Results
How to communicate on Clinical trial results
What about the publication?
Data Filing and Registration
How to file your clinical trial data and registration