De cursus zal in het engels zijn en de onderstaande leerdoelen komen aan bod. 

• Understand the general development process of a drug (pre-clinical development and phase 0–IV trials)
• Understand the framework of international laws and regulations which govern the set-up and conduct of a clinical trial
• Identify and explain the purpose of ICH-GCP
• Identify two pillars of ICH-GCP
• Identify and explain the 13 principles of ICH-GCP
• Understand when the ICH-GCP guideline is applicable
• Identify the key roles in clinical trials according to ICH-GCP
• Identify the three phases of a clinical trial: the preparation phase, the execution phase and the close-out phase
• Understand which steps are included in each of the three 
• Understand the requirements, responsibilities and tasks of the investigator in the three phases of a clinical trial