Instructor-led courses

Overview

Health Products Regulation and Prequalification Learning Catalogue

Below you will find instructor-led courses.

• WHO Good Regulatory Practices
• Assessors Training: The WHO Global Benchmarking Tool to Benchmark Regulatory Authorities
• Quality management system implementation workshop
• Regulatory performance indicators
• WHO-Swissmedic Regulatory Peer Training
• Regulatory Preparedness for Provision of Marketing Authorization of Vaccines in Public Health Emergencies
• Assessment of bioequivalence studies
• Basic Training on the Assessment of Dossier in the Common Technical Document Format
• Substandard and Falsified Medical Products: Prevention, Detection, Response
• Post-market and Market Surveillance of In Vitro Diagnostics for Testing Providers and Regulators
• Principles of Scientific Assessment of an In Vitro Diagnostic Dossier: Demonstration of Quality, Safety and Performance and the Procedural/Administrative Aspects of Technical Files Assessment and Marketing Authorization within the National Regulatory Authorities
• GMP inspection: basic course
• GMP inspection: advanced course
• GMP: deficiencies classification
• Good Storage and Distribution Practices Regulatory Inspections Using a Risk-Based Approach
• National AEFI data management training using Vigitools
• Vaccine safety basics course
• Vaccine safety communication course
• National AEFI guidelines dissemination course
• Intermediate course on AEFI
• AEFI signal detection course
• Advanced course on AEFI and causality assessment
• AEFI field investigation and communication simulation course
• AEFI causality assessment for AEFI review committee members
• Prequalification of Medicines Annual Training for Regulators: Quality Assessment
• Prequalification of Medicines Annual Training for Regulators: Biotherapeutic Product and Similar Biotherapeutic Product Assessment