Introduction to Pharmacovigilance (PV)
Periodic Reporting and Risk Management
PV System Quality and Audits
Case Processing
Individual Case Safety Reports (ICSRs)
Signal Detection and Safety Monitoring
Specialized Vigilance
Practical Skills Development
Pharmacovigilance is the science and activities involved in the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Its primary goal is to enhance patient safety by monitoring and evaluating the safety and efficacy of medications throughout their lifecycle, from development to post-market surveillance. This program provides practical training related to Pharmacovigilance Professional job function and covers all the activities to promote successful studying of drug’s adverse effects, compliance with EU and FDA standards as well as proper report building (ICR, PSUR) and real case studies. The program also describes the statistical methods adapted to Pharmacovigilance, in addition to cosmeto-vigilance, materiovigilance and the proper use of the MedDRA. Upon program completion, participants will be provided a professional diploma from USEK and ClinAcademy
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