What is the role of the designated person, responsible for pharmacovigilance within a sponsor company?
For high risk medicines and blood products, product licence holders would need to appoint a “Designated Person” who would be responsible for the oversight of the complete vigilance system for that product. This would include quality control and assurance procedures, standard operating procedures, database operations, compliance data, audit reports and training of personnel in relation to product vigilance. In addition, the person is responsible for the investigation of complaints, and adverse events, and the submission of reports to the agency in relation to reportable events and other information. The Designated Person for each product licence holder should be a resident in Australia or New Zealand and should have access to appropriate knowledge regarding the practice of medicine in the Australian and New Zealand health systems. What is the role of risk management plans in the product vigilance system? All applications for a product licence for a high risk medicine or blood must inclu
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