Signal Management in Pharmacovigilance 2017

Signal Management in Pharmacovigilance is organized by Drug Information Association / Develop Innovate Advance (DIA) and would be held during Feb 22 - 23, 2017 at Holiday Inn London - Kensington Forum, London, England, United Kingdom.

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.

Learning Objectives:

At the conclusion of this training course participants wil 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.