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
DIA has blocked a limited number of rooms at the following hotel:
Hotel Novotel Paris Charenton
3-5 place des Marseillais
94227 CHARENTON LE PONT
at the rates of EUR 150.00 per room inclusive of breakfast and exclusive of VAT.
To make your reservation please use the hotel booking form.
Important: The room rate is available until 22 September 2014 or until the group block is sold-out, whichever comes first.
In case of cancellation: The room can be cancelled 43 hours prior arrival, after that the credit card will be charged for the 1st night.
The Hotel Novotel Paris Charenton is located 10 minutes from Gare de Lyon train station, the vibrant Bastille district & Bercy. The liberté metro station (line 8) opposite the hotel gives direct access to Paris's main attractions like Place de la Concorde, Eiffel Tower, Opéra, etc.