Executive Development Programme in Drug Safety & Regulatory Strategies
-- ViewingNowThe Executive Development Programme in Drug Safety & Regulatory Strategies is a certificate course designed to provide learners with critical insights into drug safety and regulatory strategies. This program emphasizes the importance of effective pharmacovigilance, risk management, and regulatory compliance in the biopharmaceutical industry.
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⢠Introduction to Drug Safety & Pharmacovigilance: Understanding the basics of drug safety, pharmacovigilance, and their importance in public health.
⢠Regulatory Landscape for Drug Safety: Overview of domestic and international regulations governing drug safety and pharmacovigilance.
⢠Adverse Event Reporting & Management: Processes and systems for monitoring, reporting, and managing adverse drug reactions.
⢠Risk Management Strategies: Techniques for assessing, mitigating, and communicating risks associated with drug products.
⢠Pharmacoepidemiology & Pharmacovigilance: The role of pharmacoepidemiology in drug safety, including post-marketing surveillance and observational studies.
⢠Regulatory Affairs & Life Cycle Management: Managing drug safety throughout the product life cycle, including regulatory affairs and interactions with regulatory agencies.
⢠Drug Safety in Clinical Trials: Ensuring drug safety in clinical trials, including safety monitoring and reporting.
⢠Quality Management Systems for Drug Safety: Implementing and maintaining quality management systems for drug safety and pharmacovigilance.
⢠Ethical & Legal Considerations in Drug Safety: Ethical and legal considerations in drug safety, including patient confidentiality and informed consent.
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