Global Certificate in Regulatory Affairs for CRAs
-- ViewingNowThe Global Certificate in Regulatory Affairs for CRAs is a comprehensive course designed to provide learners with the essential skills and knowledge required for success in the regulatory affairs field. This certificate course focuses on global regulations, ensuring learners are well-equipped to navigate the complex regulatory landscape.
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โข Regulatory Affairs Fundamentals: Introduction to Regulatory Affairs, Regulatory landscape, Role of Clinical Research Associates (CRAs) in Regulatory Affairs
โข Regulatory Strategies: Global regulatory strategies, Regional regulatory requirements, Adaptive pathways
โข Regulatory Documentation: Clinical trial applications, Investigational new drug (IND) applications, Common Technical Document (CTD) structure
โข Regulatory Submissions: Preparation and submission of regulatory documents, Electronic submissions via eCTD, Regulatory agency communication
โข Pharmacovigilance: Pharmacovigilance principles, Adverse event reporting, Periodic safety update reports (PSURs)
โข Regulatory Inspections: Preparing for and managing regulatory inspections, Inspection readiness, FDA and EMA inspection processes
โข Regulatory Compliance: Regulatory compliance requirements, Quality assurance, Good Clinical Practice (GCP) guidelines
โข Regulatory Intelligence: Monitoring regulatory changes, Regulatory intelligence platforms, Regulatory impact assessments
โข Labeling and Post-Marketing Activities: Product labeling, Post-marketing surveillance, Post-approval changes
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