Executive Development Programme in Drug Safety & Quality Assurance
-- ViewingNowThe Executive Development Programme in Drug Safety & Quality Assurance is a comprehensive certificate course designed to provide learners with critical skills in drug safety and quality assurance. This program is essential for professionals seeking to advance their careers in the pharmaceutical industry, where drug safety and quality are paramount.
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โข Introduction to Drug Safety & Quality Assurance: Understanding the importance of drug safety, the role of quality assurance, and the regulatory frameworks governing drug development and approval.
โข Pharmacovigilance: Principles and practices of monitoring, assessing, and preventing adverse drug reactions, including signal detection, risk management, and benefit-risk assessment.
โข Good Manufacturing Practices (GMP): Overview of the guidelines and regulations for ensuring the quality and consistency of pharmaceutical manufacturing processes, including quality control, documentation, and change management.
โข Quality Assurance and Risk Management: Strategies and tools for identifying, assessing, and mitigating risks in drug development and manufacturing, with a focus on quality management systems, auditing, and continual improvement.
โข Regulatory Affairs and Compliance: Understanding the regulatory landscape and requirements for drug development and approval, including U.S. Food and Drug Administration (FDA) regulations, European Medicines Agency (EMA) guidelines, and International Council for Harmonisation (ICH) standards.
โข Clinical Trials and Data Management: Best practices for designing, conducting, and analyzing clinical trials, including data integrity, validation, and security.
โข Drug Development Strategy: Strategic planning and decision-making in drug development, including portfolio management, resource allocation, and stakeholder communication.
โข Ethical and Legal Considerations: Ethical and legal issues in drug development and safety, including patient consent, data privacy, and intellectual property.
โข Emerging Trends and Future Directions: Emerging trends and future directions in drug safety and quality assurance, including the use of artificial intelligence, real-world data, and personalized medicine.
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