Reasons to attend
Risk Based Monitoring is a hot topic nowadays. It must be implemented in your organisation, but you do not know how to do it and where to start? Our blended learning programme for implementing Risk Based Monitoring is the ideal solution for you then. The combination of eLearning and classroom training allows you to assimilate the theoretical concepts at your own pace, whilst you have the opportunity for interacting with our experts and sharing experiences during the interactive classroom part.
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
This course is a blended learning course, which means it is broken into two parts. The eLearning session must be attended before the face to face training as its content fits to the practical approach during face-to-face training.
Classroom with eLearning:
- eLearning: 6 hours
- 1-Day face-to-face: 09:00 - 17:00
Webinars with eLearning:
- eLearning: 6 hours
- 2 webinar sessions
This blended course introduces the ins and outs of risk-based monitoring in clinical trials. It will give you the rationale for implementing this new approach and how to set it up within your organisation as recommended by ICH-GCP E6 (R2). Through an interactive approach, it will provide you with the basics for risk-based monitoring processes applied to clinical trials. You will learn how to define, evaluate and respond to risks, and also how to define the critical data, the risk indicators and the thresholds linked to it. Additionally, you will go through the different steps to be taken for implementing this new monitoring methodology. The roles and responsibilities of each stakeholder will be discussed as well. The classroom session will provide cases and workshops on the eLearning content, allowing you to implement it in your daily practice. Lively discussions and action planning sessions with all participants are the main components of the classroom part. Here you will benefit not only from the trainer’s but also learn from each other’s experiences. Seasoned industry experts contribute to this programme by providing their real-life experience, including a live demonstration of a Risk Based Monitoring enabling technology. The complementary eLearning course includes interactive quizzes and exercises for self-assessment to provide a better understanding of each part of the course. You will be able to test your comprehension with a final grading assessment. Click the link to open the Course Programme and get detailed information about the course structure and chapters duration.