What you will learn
- How to comply with the ICH-GCP and other clinical trial related regulations and guidelines, when conducting and monitoring clinical trials.
- What the roles of the involved authorities are – and how to interact both as investigator and as sponsor
- How roles and responsibilities are defined for sponsor/CRO and site - and how you can optimize the collaboration between the involved partners
- How to collect, monitor and file clinical trial related data throughout the clinical trial
- The importance of timely and accurate management of safety data
- The importance of correct handling of study medication from packaging to destruction
What your company will get
- A GCP professional who knows the essence of current ICH-GCP and how to ensure compliance
- A GCP professional who can provide valuable input to other team members regarding ICH-GCP guidelines and relevant regulations
- A GCP professional who knows the principles and practical aspects of effective site monitoring
- An employee who knows how the importance of good collaboration with relevant stakeholders in clinical trials
- An employee who understands the responsibilities and duties of both investigator and sponsor