Executive Development Programme in Drug Safety for Biotech
-- ViewingNowThe Executive Development Programme in Drug Safety for Biotech is a certificate course designed to provide learners with critical skills in drug safety for the biotech industry. This program emphasizes the importance of drug safety in biotech, pharmaceutical, and regulatory sectors, addressing the growing industry demand for experts in this field.
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โข Introduction to Drug Safety: Understanding the fundamentals of drug safety, including key concepts and regulatory frameworks.
โข Pharmacovigilance: An in-depth look at pharmacovigilance, including its importance, processes, and best practices.
โข Risk Management: Strategies for identifying, assessing, and mitigating risks associated with drug development and use.
โข Clinical Trials: The role of drug safety in clinical trials, including safety monitoring, adverse event reporting, and data analysis.
โข Regulatory Compliance: Ensuring compliance with drug safety regulations, including reporting requirements and safety data submissions.
โข Signal Detection and Evaluation: Techniques for detecting and evaluating safety signals, including statistical analysis and risk assessment.
โข Drug Safety Communication: Communicating drug safety information to stakeholders, including healthcare providers, patients, and regulatory agencies.
โข Drug Safety in Special Populations: Considerations for drug safety in special populations, including children, elderly, pregnant women, and those with underlying medical conditions.
โข Pharmacoepidemiology: The study of the use and effects of drugs in large populations, including post-marketing surveillance and epidemiological methods.
โข Quality Assurance and Improvement: Implementing quality assurance and improvement processes in drug safety, including audits, inspections, and continuous improvement initiatives.
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