Participants will gain a solid understanding of the role and responsibilities of the Qualified Person for Pharmacovigilance (QPPV), the Pharmacovigilance System Master File (PSMF), ICSR handling, MedDRA coding, and safety management in clinical trials.
The program also covers signal management, risk minimization, and preparation for audits and inspections. Through hands-on exercises and interactive workshops, participants will be able to apply their knowledge directly in their day-to-day work and further strengthen their pharmacovigilance expertise.
The training combines expert knowledge with practical examples and cross-functional perspectives, making it a valuable learning experience for professionals from Pharmacovigilance, Regulatory Affairs, Quality, Medical Affairs, Clinical Development, and related functions.