During this course you will learn about polish health authority requirements for additional risk minimization measures. You will receive a big package of practical information that will help you in future to smoothly prepare for your submission of the additional risk minimisation measures to polish health authority.
The course is divided in to 9 units. To each unit one learning outcome is assigned, which focuses on discussing a specific issue.
During this course you will learn about requirements, guidelines and expectations of the Polish health authority concerning additional risk minimisation measures. Moreover you will learn how to submit additional risk minimisation measures to the Polish health authority; how the process of assessment and approval looks like and finally how to prepare a local distribution plan. You will also learn how the co-distribution process with other marketing authorisation holders should look like. You will study the expectations of the Polish health authority in the context of distribution effectiveness assessment and issues regarding archiving documentation concerning distribution process. At the end you will learn how to manage the process of preparing, maintaining, submitting and updating additional risk minimisation measures in accordance with the local requirements of the Polish health authority.
