Curriculum
- 4 Sections
- 18 Lessons
- 1 Day
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- Introduction to Pharmacovigilance Data3
- Data Quality Management and Governance5
- 2.1Principles of Data Quality Management
- 2.2Case study: Implementing data quality checks in adverse event reporting systems.
- 2.3Data Governance in Pharmacovigilance
- 2.4Case study: Developing a data governance framework for pharmacovigilance.
- 2.5Components of data governance: policies, standards, processes, roles and responsibilities.
- Data Analysis Methods in Pharmacovigilance8
- 3.1Introduction to data analysis methods used in pharmacovigilance.
- 3.2Case study: Analyzing safety data from clinical trials using descriptive statistics.
- 3.3Principles of signal detection in pharmacovigilance.
- 3.4Methods for signal detection
- 3.5Case study: Detecting and assessing safety signals in post-marketing surveillance data.
- 3.6Risk Assessment and Management
- 3.7Techniques for risk assessment
- 3.8Case study: Assessing the risk of adverse events associated with a new drug.
- Practical Applications and Case Studies2