Executive Development Programme in Drug Safety & Clinical Data Management
-- ViewingNowThe Executive Development Programme in Drug Safety & Clinical Data Management is a certificate course designed to provide learners with critical skills in drug development and clinical data management. This program emphasizes the importance of safety regulations, protocol design, data collection, and analysis in clinical trials, ensuring learners are well-equipped to navigate the complex regulatory landscape of the pharmaceutical industry.
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⢠Introduction to Drug Safety & Pharmacovigilance: Understanding the basics of drug safety, pharmacovigilance, and their importance in clinical data management.
⢠Clinical Data Management Fundamentals: Overview of clinical data management, including data collection, validation, and reporting.
⢠Adverse Event Reporting and Management: Best practices for identifying, documenting, and reporting adverse events during clinical trials.
⢠Clinical Data Analysis & Interpretation: Techniques for analyzing and interpreting clinical data to ensure drug safety and efficacy.
⢠Regulatory Compliance in Drug Safety: Overview of regulations and guidelines governing drug safety and clinical data management.
⢠Electronic Data Capture (EDC) Systems: Introduction to EDC systems, their benefits, and how to implement them in clinical trials.
⢠Data Quality Assurance & Control: Strategies for ensuring data quality, including data validation, audit trails, and quality control checks.
⢠Risk Management in Clinical Trials: Identifying and mitigating risks in clinical trials, including data security and patient safety risks.
⢠Effective Communication in Drug Safety: Best practices for communicating drug safety information to stakeholders, including regulatory agencies, healthcare professionals, and patients.
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