Developing a risk management plan (RMP) can be a complex process, requiring the collation of information from various departments, using complex templates and complying with various guidelines. This workshop will guide you through the process of producing a RMP with opportunities to view differing approaches in industry.
What you will learn;
RMPs provide challenges and it is essential to understand the various issues including the
interpretation of signals in the integrated safety summary, gathering external data on background rates of disease, drug use and the clinical management of the disease indication. Emphasis will be placed on the enhanced need to address the quantitative aspects of RMP and risk minimisation. Writing a RMP requires hands-on experience, hence this workshop will allow you to take part in real-life practical case studies and group discussions.
09.00
Registration & coffee
09.30
Introductions and objectives
09.45
RMP EU and USA
10.15
EU- RM template
10.45
Practical case - group learning exercises
11.00
Morning coffee
11.30
EU- RM template continued
13.00
Lunch
14.00
Applying epidemiological and signal detection strategies to enhance RM
