![]() Implement the Pharmacovigilance (PV) in a more efficient and effective way. ![]() Of all these points is the need of the hour for Pharmacovigilance audience which will be helpful to Old and new Legislation, How successful are we? What challenges are we facing? Understanding The new Legislation module VII but none of them have highlighted the differences between In the literature, various articles have been published regarding ![]() Medicinal product and promises much more, but after more than 6 years, how much new lesiglation The new legislation mainly focuses on benefit-risk assessment of There are twice as many sections to the new PSUR as compared to ICH E2C (R1) document and Module VII provides the guidance for the preparation, submission and assessment of PSURs. Practices (GVP) modules came into effect by replacing Vol 9A guidelines. In July 2012, as per the new European Legislation, 16 Good Pharmacovigilance Periodic safety update report (PSUR) is now known as the Periodic Benefit-Risk Evaluation
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