Certificate in EU Pharmacovigilance Reporting
-- ViewingNowThe Certificate in EU Pharmacovigilance Reporting is a comprehensive course designed to equip learners with critical skills in drug safety monitoring and reporting within the European Union. This program emphasizes the importance of adhering to EU pharmacovigilance regulations, ensuring compliance and minimizing risks.
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โข Introduction to Pharmacovigilance Reporting in the EU
โข Understanding EU Pharmacovigilance Legislation and Guidelines
โข Adverse Event Reporting and Management in the EU
โข EU Pharmacovigilance Reporting Tools and Systems
โข Quality Management in EU Pharmacovigilance Reporting
โข EU Pharmacovigilance Reporting for Marketing Authorisation Holders
โข EU Pharmacovigilance Reporting for Clinical Trials
โข Safety Signal Detection and Management in the EU
โข Risk Management Planning for Pharmacovigilance in the EU
โข Periodic Safety Update Report (PSUR) Preparation and Submission in the EU
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