Global Pharmacovigilance Training Course

This course focuses on global regulatory requirements for the management of product safety data from clinical trial and postmarket sources. Significant regulatory changes and their impact to sponsors and marketing authorization holders is reviewed and discussed. Several topics are covered in this course, including the assessment of adverse events in individual case safety reports to determine expedited or periodic reporting, MedDRA coding, signal detection, data mining, risk management, and crisis management. In addition, CIOMS initiatives, ICH guidance documents, and local regulations is reviewed as they relate to the topics discussed in this course. This course is highly interactive, as participants have the opportunity to work in small groups to discuss case studies and manage a safety data crisis.