Signal Management in Pharmacovigilance

Overview:

The focus of the Signal Management in Pharmacovigilance 3 half days online training will be to provide a holistic and a detailed approach on activities and processes regarding ongoing safety evaluation and review of the benefit risk of medicinal products while performing signal detection and management.

During this training participants will have the opportunity to get an insight on the current signal detection and management guidelines and tools.

What are the authorities’ expectations and findings in the signal management area? During the signal management session, pragmatic approaches, real life examples, lessons learned, as also processes for signal management and eRMR assessment will be discussed.

The training will provide practical advice on signal management methods (qualitative/quantitative), assessment and how it is connected in the writing and preparation of PBRERs and RMPs.

Finally, during this training an outlook of the interactions between Drug Safety and other internal (e.g. Regulatory Affairs) and external stakeholders (health Authorities) will be given.

How we communicate efficiently signals, Emerging safety issues (ESISs) and other safety communications (i.e. DHPCs) will be discussed.

This course is intended for professionals working within the pharmaceutical industry in pharmacovigilance, clinical safety, safety risk management and medical writing positions.

Junior Drug Safety and Pharmacovigilance professionals within pharmacovigilance and medical writing will benefit from this training by getting a more in depth course in signal management, benefit-risk and safety periodic writing as also more senior professionals who wish to extend their professional skills in signal management.

‍

Learning objectives

Upon completion of the course, participants will:

• Principles, basic definitions, and frameworks for signal management
• Qualitative and quantitative signal management
•  Signal management in clinical development
• Interconnection of Signals and PBRERs
• Interconnection of signals and RMPs
• Cross functional collaboration
• Case studies

List of who should attend:

• Safety physicians /scientists
• Pharmacovigilance experts
• Medical writers
• Safety Risk managers
•  Signal management experts
• Clinical safety scientists
• QPPVs

‍

Draft Schedule:

DAY 1:

1. Global Guidelines on Signal Management
2. Definitions and introduction to signal management
3. Qualitative signal detection (examples and best practices)
4. Quantitative signal detection (Data mining)

‍