Executive Development Programme in High-Performance Drug Regulation
-- ViewingNowThe Executive Development Programme in High-Performance Drug Regulation is a comprehensive certificate course designed to equip learners with critical skills in drug regulation. This program emphasizes the importance of effective regulatory strategies in the pharmaceutical industry, addressing key issues such as safety, efficacy, quality, and patient access.
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⢠Drug Regulation Fundamentals: Overview of drug regulation, history, and current landscape
⢠Regulatory Frameworks: Comparison of global regulatory frameworks and their impact on high-performance drug regulation
⢠Pharmacovigilance: Importance of pharmacovigilance in drug regulation and adverse event reporting
⢠Clinical Trials: Regulation of clinical trials, ethical considerations, and best practices
⢠Drug Approval Process: Understanding the drug approval process, including expedited and special designations
⢠Quality Assurance: Implementing quality assurance in drug manufacturing, packaging, and distribution
⢠Inspection and Enforcement: Strategies for effective inspection and enforcement in drug regulation
⢠Emerging Trends: Exploring emerging trends in drug regulation, including personalized medicine and digital health
⢠Stakeholder Management: Effective communication and collaboration with industry, regulatory agencies, and other stakeholders
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