Drug safety monitoring and risk management are vitally important for medicinal product developers, licence holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.
Entry-level staff, and those seeking a refresher, in drug safety / pharmacovigilance and clinical departments will find the course invaluable, as will clinical investigators and other healthcare professionals. Staff in other departments of pharmaceutical and biotechnology companies will benefit from taking the course to gain an appreciation of the basics of the subject.
Module overview - 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.
Assessment - Multiple-choice mastery assessment.