Overview
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.
“DIA events provide the ideal platform to exchange experience with colleagues across the industry and the trainings are really of a very high utility.”
Munish Kumar Kaushik, Associate Director, Jubilant Generics Ltd.
"The course was well organized, very good trainer with clear messages."
Dr. Irina Galiuc, Local Drug Safety Unit Manager, Berlin-Chemie A. Menarini SRL Romania
"This course was the best training for signal detection management what I have ever attended."
Dorota Zlochova, PV and Medical Affairs officer CEE, Chiesi Pharmaceuticals GmbH
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