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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.
Who Should Attend
Professionals who work in:
- Pharmacovigilance (including QPPV)
- Drug safety and patient safety Risk Management
- Information Technology
- Regulatory Affairs
- Pharmacovigilance consultancy
- Quality and Compliance
Level: For professionals with 2-3 years of experience in Pharmacovigilance. This course will be at intermediate level.
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 on the uses of statistical signal detection methods in the Eudravigilance Data Analysis System, Module IX of EU GVP and CIOMS VIII
- Understand and manage implications of Pharmacovigilance signals for the future of pharmaceutical companies and products
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