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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⢠Introduction to Pharmacovigilance Reporting in the EU
⢠Understanding EU Pharmacovigilance Legislation and Guidelines
⢠Adverse Event Reporting and Management in the EU
⢠EU Pharmacovigilance Reporting Tools and Systems
⢠Quality Management in EU Pharmacovigilance Reporting
⢠EU Pharmacovigilance Reporting for Marketing Authorisation Holders
⢠EU Pharmacovigilance Reporting for Clinical Trials
⢠Safety Signal Detection and Management in the EU
⢠Risk Management Planning for Pharmacovigilance in the EU
⢠Periodic Safety Update Report (PSUR) Preparation and Submission in the EU
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