In the past 20 years, many low- and middle-income countries have created national pharmacovigilance (PV) systems and joined the global PV network. In addition, many countries continued to follow the ICH-Good Clinical Practices (GCP). However, very few of them have fully functional systems. Scientific evidence on the local burden of medicine-related harm and their preventability is missing. Legislation and regulatory framework, as well as financial support to build sustainable PV and Clinical Research (CR) systems, are needed. Public health programs need to integrate PV and CR to monitor new vaccines and medicines that are investigated and introduced through these programs. Signal analysis should focus on high-burden preventable adverse drug problems. Increased involvement of healthcare professionals from public and private sectors, pharmaceutical companies, academic institutions and the public at large is necessary to assure a safe environment for drug therapy.
This course introduces students to global clinical trials activities and global pharmacovigilance systems and processes in various organizations and countries.
This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Clinical Research, Drug Safety, and Pharmacovigilance.