Advanced Certificate in Pharmacovigilance Reporting Guidelines
-- ViewingNowThe Advanced Certificate in Pharmacovigilance Reporting Guidelines course is a comprehensive program designed to provide learners with the essential skills needed to excel in pharmacovigilance. This course covers the latest reporting guidelines, ensuring learners are up-to-date with industry standards and regulations.
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⢠Introduction to Pharmacovigilance Reporting Guidelines: Overview of Pharmacovigilance, its importance, and the role of reporting guidelines. ⢠Regulatory Framework for Pharmacovigilance: Explanation of regulatory authorities, guidelines, and regulations for Pharmacovigilance. ⢠Adverse Event Reporting: Defining adverse events, their classification, and reporting criteria. ⢠Pharmacovigilance Systems and Databases: Introduction to global Pharmacovigilance systems, databases, and their role in reporting. ⢠Case Report Forms (CRFs): Designing, completing, and submitting CRFs. ⢠Signal Detection and Management: Identification, evaluation, and management of safety signals. ⢠Risk Management Plans (RMPs): Development, implementation, and monitoring of RMPs. ⢠Periodic Safety Update Reports (PSURs): Compiling, reviewing, and submitting PSURs. ⢠Pharmacovigilance Audits and Inspections: Preparation, execution, and follow-up of audits and inspections. ⢠Quality Management in Pharmacovigilance: Implementing and maintaining quality systems in Pharmacovigilance.
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