Global Pharmacovigilance Training Course: Adverse Drug Events
This course focuses on regulatory requirements that impact the management and handling of drug safety data and adverse event reporting. Significant regulatory changes from the sponsor's and FDA's view will be reviewed, including current FDA regulations and Guidances and how they will be implemented. This course will also provide an opportunity for those working in safety surveillance to gain an in-depth understanding how these regulations relate to international activities in CIOMS and ICH. This course will be highly interactive, with participants partaking in small group discussions and case studies emphasizing expedited and periodic reporting, decision-making and crisis management.