It gives us great pleasure to invite you to the Symposium on Risk Management in Auditing and Monitoring Clinical Trials (RMAM 2018), which will take place in Vienna, Austria from 25-26 June 2018.
Regulators are focusing more and more on risk-based approaches in clinical trials, and RMAM 2018 will help trial management companies understand how to assess risk for clinical trials.
The Federal and Drug Administration (FDA) and the European Medicines Agency (EMA) released guidance in 2013, and since then, risk-based monitoring has been a part of clinical trials. And now, with the revision of Good Clinical Practice guidelines (ICH E6(R2)) which includes risk management as a separate section, this focus will increase even more. This seminar aims to answer the questions:
What is risk management in general?
How will risk management in clinical trials be implemented in the existing processes?
What will be the impact of the implementation on auditing & monitoring?
How will the implementation change my daily work, responsibilities and collaboration with other parties?
RMAM 2018 will answer these questions and tackle the issues and challenges related to risk monitoring by debating, lecturing and training on this topic.
We look forward to seeing you at RMAM 2018. We know that you will have a valuable experience at the seminar and an enjoyable time in the great city of Vienna.