This course will contain introdcution into standard risk management tools and explain risk management for medicines in the US and in EU.

1 h live presentation about GVP Module I, the role and task of an QPPV and general principles of the pharmacovigilance system

Live presentation about EMA GVP Module II. Basics about the PSMF, required interactions with other departments and most commen inspection findings.

Live presentation about the EMA GVP Module III about inspections. How to prepare for inspections, what to expect, and how to deal with the findings.

1 h live session about EMA GVP Module IV. The importance of PV audits, how to plan PV audits appropriately and conduct these successfully.

1 hour live presentation about pharmacovigilance risk management in EU. How to write a risk management plan, what to consider, links to the Periodic Safety Update Report and life-cycle of the document.

1 hour presentation about EMA GVP Module VI. Highlighting important requirements, discussing the special situations and impact on the processes.

1 hour live session about EMA GVP Modul VII. Focus on requirements for writing a good Periodic Safety Update Report, the KPIs of a PSUR and how to deal with the assessment report. We will also discuss connections with the RMP.

1 hour live session about past authorisation safety studies. We will also discuss the addendum. Why PASS or PAES and the additional workload to be considered. We will also discuss work cooperations in consortiums.

1 hour live presentation about EMA GVP Modules IX and X. All about signal management and additional monitoring.

1 hour live session about EMA GVP Modules XV and XVI. We will discuss safety communication and especially educational tools. We will discuss how to write these tools, the implementation on national level as well as the monitoring of successful implementation.