The course will teach basic concepts of signal detection and signal management and how to apply them within the participants' functions, including the data mining techniques for large volume ADR data analysis, relevant EMA guidelines as well as a future outlook.
The entire course is 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.
Participants will be provided with preparatory material in order to better participate at the group exercises onsite.
The Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom has accredited this training course with 9.5 CPD credits.
The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this training course with 9.5 credits. Special rates available for SwAPP members.
DIA is an authorised training organisation accredited under the number 11 99 53383 75 to the Préfet of Ile-de-France.
What participants from previous course say:
"The course gave me good ideas to improve our signal detection management"
"It is practical and very relevant to PV department activities"
Who should attend?
- Pharmacovigilance (including QPPVs)
- Drug safety and patient safety risk management
- Information Technology
- Regulatory Affairs
- Pharmacovigilance consultancies
- Quality and Compliance
Course level: Intermediate, for professionals with 2-3 years of experience in Pharmacovigilance, or related functions who are working with Pharmacovigilance around signal management.
At the conclusion of this course, participants will be able to:
Apply the basic concepts and principles of signal detection in pharmacovigilance, from simple visualisation and tabulation methods to sophisticated data mining techniques
Design the signal management process for institutions and companies of various sizes, portfolios and geographical presence, based on the possibilities and limitations of their data and resources
Understand key messages from the current European and US regulations on signal management, to best manage implications of 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.