Certificate in Drug Development Regulations
-- ViewingNowThe Certificate in Drug Development Regulations is a comprehensive course designed to provide learners with a solid understanding of the regulations and compliance requirements in drug development. This course is crucial in an industry where staying up-to-date with regulatory changes is paramount for success.
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โข Introduction to Drug Development Regulations: Overview of global regulatory bodies, their role, and impact on drug development
โข Pharmaceutical Quality Systems: Understanding quality assurance, quality control, and regulatory expectations
โข Preclinical Research and Regulatory Requirements: Animal studies, toxicology, and IND application process
โข Clinical Trial Design and Regulations: Phases of clinical trials, GCP guidelines, and ethical considerations
โข Clinical Trial Data Management: Data collection, monitoring, and reporting in clinical trials
โข Marketing Authorization Applications: NDA, BLA, and MAA processes, CMC, and nonclinical requirements
โข Pharmacovigilance and Post-Marketing Surveillance: ADR reporting, signal detection, and risk management
โข Regulatory Inspections and Audits: Preparation, handling, and post-inspection actions
โข Regulatory Affairs in Drug Lifecycle Management: Strategies for regulatory intelligence and compliance in drug development
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