Global Certificate in Drug Safety Guidelines Essentials Basics Fundamentals
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⢠Introduction to Drug Safety: Understanding the importance of drug safety, key terminologies, and the role of drug safety guidelines in public health. ⢠Pharmacovigilance: The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. ⢠Regulatory Authorities: Overview of major regulatory authorities (FDA, EMA, etc.) and their role in drug safety guidelines. ⢠Adverse Event Reporting: Processes and systems for reporting, monitoring, and managing adverse events related to drugs. ⢠Clinical Trials: Phases of clinical trials, their importance in drug development, and safety considerations. ⢠Risk Management Plans: Development, implementation, and monitoring of risk management plans to ensure drug safety. ⢠Pharmacoeconomics: The study of the costs and benefits of pharmaceutical products and services. ⢠Drug Safety Communication: Strategies for effective communication of drug safety information to healthcare professionals and patients. ⢠Quality Assurance in Drug Safety: Implementing and maintaining quality assurance systems in drug safety practices.
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