Executive Development Programme in Drug Safety: Advanced Concepts
-- ViewingNowThe Executive Development Programme in Drug Safety: Advanced Concepts is a comprehensive certificate course that focuses on the latest trends and techniques in drug safety. This programme is crucial for professionals seeking to advance their careers in pharmacovigilance, clinical research, and regulatory affairs.
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⢠Advanced Pharmacovigilance: Understanding and managing drug safety data, signal detection and evaluation, risk management and communication, and benefit-risk assessment.
⢠Regulatory Affairs: Navigating global regulations, including ICH, FDA, and EMA guidelines, and ensuring compliance in drug safety processes.
⢠Clinical Trial Safety: Designing and implementing safety measures for clinical trials, monitoring adverse events, and reporting requirements.
⢠Pharmacoepidemiology: Utilizing epidemiological methods to assess drug safety in large populations, including post-marketing surveillance and observational studies.
⢠Risk Management Planning: Developing and implementing risk management plans, including safety specifications, benefit-risk assessments, and safety monitoring plans.
⢠Pharmacovigilance Audits and Inspections: Preparing for and managing internal and external audits and inspections, ensuring compliance with regulations and industry standards.
⢠Data Management and Analysis: Utilizing advanced data management and analysis techniques for drug safety data, including statistical analysis and visualization.
⢠Emerging Trends in Drug Safety: Exploring emerging trends in drug safety, including real-world evidence, social media monitoring, and artificial intelligence.
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