- Explain, with examples, why drug safety monitoring / pharmacovigilance is necessary
- Describe ways in which drug safety / pharmacovigilance is regulated nationally and internationally, and identify international policy-making bodies.
- Outline how drug safety / pharmacovigilance responsibilities are organised within pharmaceutical and biotechnology companies.
- Sketch how a product safety database is compiled, how a product's safety profile is assessed, and how safety information is included in documentation for regulatory authorities, healthcare professionals, and consumers.
- Apply appropriate terms to describe different types of adverse effect.
- Specify requirements to report adverse reactions to regulators.
- Outline requirements for safety data and for risk management plans in applications for marketing approval.
Describes what the course is about, sets out learning objectives, defines key terms and provides a brief overview of course content.
Regulation and company organisation
Explains the rationale for modern drug safety / pharmacovigilance (PV) regulation and practice, describes international policy-making bodies and sources of regulatory guidance, and outlines company drug safety / PV organisation, product safety databases and core safety information.
Before a product is marketed
Sets out the fundamentals of pre-marketing drug safety / PV: safety information for investigators, describing adverse effects, clinical trial reporting requirements, safety data in marketing applications, risk management planning, and product information.
After a product is marketed
Sets out the fundamentals of post-marketing PV: monitoring adverse drug reactions, licence holders' reporting requirements, detecting and testing safety signals, assessing benefit/risk balance, risk minimisation, communicating new safety information, product withdrawal.
Quality system, inspections and audits
Describes measures, increasingly emphasised by regulators, to ensure adequate performance of a PV system: the organisation's PV quality system, regulatory inspections, and audits.
Review and further information
Summarises key points and provides links to important guidance documents and other reference sources.
Multiple-choice mastery assessment.