Risk and issue management is quite popular topic in the project management courses. It is also very important process during conduct the clinical trials. Well risk management can reduce the possibility to become the issues; well issue management can prevent the same issues occur in the further. The objectives of this training are to let all attendees have general concepts for risk and issue management in clinical trials including the following five topics: • Definition for Risk and Issue • Quality management from ICH GCP R2 • Operations in Clinical Trials for risk management • Issue Management in Clinical Trials • Case study for Issue Management