“Pharmacovigilance & Vigilance” Project will provide integrated knowledge and broad perspectives about all the regulations and regulatory requirements for the Pharmacovigilance (PV) system for the drugs and biologics and the Vigilance system for medical devices. The PV project will prepare the PV employees to effectively manage all the Pharmacovigilance and vigilance duties using the Pharmacovigilance System Master file (PSMF/ PSSF) and the PVEX-Pro Software.
1- PSMF/ PSSF System File.
2- PSMF/ PSSF-related SOPs including:
3- PSMF/ PSSF-Related Forms:
2-year subscription with up to 4 users for a cloud-based PV software that will be used simultaneously with the PSMF/ PSSF file.
2 Weeks of Consultation following the setup of the PV system and PVEX-pro software.
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