During this course you will learn the specifics of the Polish market in terms of the Risk Management Plan.

You will receive a package of practical information that will help you in future to smoothly prepare for your submission of the Risk Management Plan to Polish Health Authority.

The course is divided in to 6 units. To each unit one learning outcome is assigned, which focuses on discussing a specific issue.

You will learn the process of submitting Risk Management Plan to the Polish Health Authority in national procedures. Moreover youI will study the timetable for the assessment and approval of Risk Management Plan by the Polish Health Authority. You will also learn how to identify safety concerns in line with local guidelines. You will study how to plan a proposal and implementation of additional risk minimization measures and how to measure the effectiveness of these in accordance with local guidelines. You will learn how to manage the process of preparing, maintaining, submitting and updating Risk Management Plan in accordance with local guidelines. Finally at the end you will learn how to identify situations for which it is recommended to prepare and submit new Risk Management Plan.