Description
Who is this for?
The Introduction to Pharmacovigilance in Good Distribution Practice is for those working as RPs (Responsible Persons), Wholesalers, Distributors, Product Quality and the Supply Chain. Pharmacovigilance is not optional, but an absolute requirement and pivotal to patient safety and has to be observed, exercised and applied in all areas.
What’s the objective?
The course is designed to help you understand the foundational principles of pharmacovigilance, its purpose, where it is involved in the drug lifecycle and how it impacts Good Distribution Practice. You will also learn about how it was conceived and why, the systems involved in ensuring its application, and the procedures involved.
Discover the foundational principles and definitions of pharmacovigilance, including the distinction between adverse events and adverse drug reactions. The course explores the regulatory framework governing PV, the ethical necessity of monitoring medicine safety throughout the drug lifecycle, and the specific impact of PV on distribution activities.
What Will I learn?
Key learning areas include the management of spontaneous safety reports, the implementation of additional risk minimisation measures, the execution of patient support programmes, and the importance of regular data reconciliations and audits. Ultimately, you will understand how to maintain compliance and fulfil pharmacovigilance obligations within Good Distribution Practice.
