Executive Development Programme Veterinary Regulatory Affairs
-- ViewingNowThe Executive Development Programme in Veterinary Regulatory Affairs certificate course is a comprehensive program that equips learners with the essential skills needed for career advancement in the veterinary industry. This course emphasizes the importance of regulatory affairs, an area of increasing demand as global regulations for animal health products become more complex.
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โข Introduction to Veterinary Regulatory Affairs: Understanding the regulatory landscape, key players, and the importance of regulatory compliance in the veterinary industry.
โข Veterinary Drug Development: Overview of the drug development process, including preclinical and clinical trials, regulatory submissions, and approval pathways.
โข Regulatory Strategies: Developing effective regulatory strategies, including risk management, product lifecycle management, and labeling considerations.
โข Quality Assurance and Control: Implementing quality management systems, Good Manufacturing Practices (GMPs), and other quality assurance and control measures.
โข Regulatory Submissions and Approvals: Navigating the regulatory submission process, including Chemistry, Manufacturing, and Controls (CMC) submissions, and understanding the role of regulatory agencies in the approval process.
โข Post-Marketing Surveillance and Pharmacovigilance: Overview of post-marketing surveillance and pharmacovigilance, including adverse event reporting, signal detection, and risk management.
โข International Regulatory Affairs: Understanding the global regulatory landscape, including international harmonization efforts, and regulatory requirements in key markets.
โข Regulatory Compliance and Inspections: Implementing compliance programs, preparing for inspections, and responding to regulatory actions.
โข Ethics and Professionalism in Regulatory Affairs: Understanding ethical considerations and developing professional skills in regulatory affairs, including communication, negotiation, and leadership.
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