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.
What the participants from previous Signal Management courses say:
"Very good presentations, clear explanations and useful, partial examples. All exercises were well chosen and useful for my daily notice"
"Good combination of information and exercises, and interaction throughout"
"Excellent knowledge, open to questions, ready to assist and to provide additional explanations"
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
Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.
Hotel & Travel
The course will take place at:
Hotel Century Old Town
Na Porici 7
110 00 Prague 1
Tel: +420 2 21 800 807
After 11 April the hotel rooms are subject to availability. Please contact the hotel for availability and prices.
How to get there: from the airport take the Airport Express to Námestí Republiky/Republic Square (travel time 35 min, price CZK 60). From there turn into Na Porici street. The hotel is within 2 min walk.
Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52