En bref :
Signal Management is a critical process of Pharmacovigilance required by EU Good Pharmacovigilance Practice. It is the scientific component that underpins Pharmacovigilance, and the very reason why Pharmacovigilance was created in the first place.
The entire course has been updated in line with the latest guidelines on EU Good Pharmacovigilance Practices (GVP): Module IX - Signal management, Commission Implementing Regulation (EU) No. 520/2012, and CIOMS VIII.
Time has been set aside for exercises, questions and discussions.
The course will teach basic concepts of signal detection and signal management and how to apply them within the participants' functions. Data mining techniques for large volume ADR data analysis and relevant EMA guidelines will also be a discussed, as well as a future outlook.
Who Should Attend
Professionals who work in:
Pharmacovigilance (including QPPV)
Drug safety and patient safety Risk Management
Pharmacoepidemiology
Information Technology
Regulatory Affairs
Pharmacovigilance consultancy
Quality and Compliance
Legal
Course level: Intermediate, for professionals with 2-3 years of experience in Pharmacovigilance.
Learning Objectives
At the conclusion of this course, participants should be able to:
Explain and design the signal management process for companies of various sizes, portfolios and geographical presence
Explain and apply the basic concepts and principles of signal detection in Pharmacovigilance, including the role and differences of classical and statistical signal detection in the ongoing safety surveillance of medicinal products
Outline how to apply signal detection within their function based on the possibilities and limitations of methodology, data and resources
Employ data mining techniques to analyse large volumes of adverse event report data
Discuss key messages from the EMA Guideline
