Training Course Goals

• Describe the expedited and periodic ICSR reporting requirements in development and post-marketing
• Discuss the challenges regarding MedDRA and reporting special situations
• Outline the required Quality Management System including PSMF, QPPV, audits and inspections in pharmacovigilance
• List the principles of signal management
• Describe the components of risk management in pharmacovigilance

Day 1 | Post-Marketing

Day 1 corresponds to GVP Modules VI and VII and will cover individual and periodic adverse reaction reporting requirements of marketing authorisation holders in the post-authorisation phase with illustrations based on case studies as practical examples.

Day 2 | Regulatory Aspects

Day 2 covers GVP Modules I to IV and will provide the safety reporting requirements with case studies from clinical trials with marketed products. It gives guidance on the coding with MedDRA and the use of MedDRA queries (SMQs) in assessment. Furthermore, it covers high level the requirements of the Quality Management System for Pharmacovigilance and includes aspects as well as preparation and conduct of audits and inspections.

Day 3 | Risk Management

Day 3 corresponds to GVP Modules V, VIII, XV and XVI. In accordance with the GVP Module V on Risk Management System, Risk Management Plans (RMPs) should be submitted by companies to propose activities aiming to identify, characterise or minimise risks associated with medicinal products. Given the potential public health implications and costs of such interventions, RMPs should be based on robust data. Specific examples of data collection and analysis will be presented in this session. Besides, pharmaco-epidemiological studies, which are the fundamentals of “additional” Pharmacovigilance activities, are discussed. This session also presents recent developments regarding risk communication.

Day 4 | Signal Management

Day 4 covers GVP Modules IX and X. New safety signals may emerge at any time following product launch and must be evaluated for relative risk, medical importance, and likelihood of occurrence. Signal Management is, therefore, one of the crucial “routine” Pharmacovigilance activities. Approaches to Signal Management using qualitative and quantitative methods will be illustrated from the industry side, as well as from the regulatory side by EMA and MEB. This will be presented in a workshop with examples as well as general considerations on signal management in the EEA.