The participation in the eLearning training is free of charge for those applicants that will be admitted

Live opening event

Schedule: 27/11/2023
14:00 – 15:30

Agenda

Module 01 - EU legal provisions

Schedule: 27/11/2023 – 01/12/2023

Programme

Module 02 - Licensing, authorisation and accreditation system (including overview of inspection tools)

Schedule: 04/12/2023 – 07/12/2023

Programme

Module 03 - Quality management system - Overview

Schedule: 11/12/2023 – 15/12/2023

Programme

Module 04 - Quality Management System – Good practices

Schedule: 18/12/2023 – 22/12/2023

Programme

Module 05 - Quality risk assessment

Schedule: 08/01/2024 – 12/01/2024

Programme

Module 06 - BTC preparation process authorisation

Schedule: 15/01/2024 – 19/01/2024

Programme

Module 07 - SoHO Vigilance and Biovigilance

Schedule: 22/01/2024 – 26/01/2024

Programme

Module 08 - Serious adverse outcomes/rapid alerts and Harmonizing data collection

Schedule: 29/01/2024 – 02/02/2024

Programme

Module 09 - Stock and critical supplies, Import/export, Single coding

Schedule: 05/02/2024 – 09/02/2024

Programme

Module 10 - Inspection practice, inspection report and post inspection activities

Schedule: 12/02/2024 – 16/02/2024

Programme

Module 11 - Risk for inspectorate

Schedule: 19/02/2024 – 23/02/2024

Programme

Round 1 - Live closing event

Schedule: 01/03/2024
14:00 – 15:30

Agenda

Workshop 1 - Inspection practice

Schedule: 15, 16, 17 May 2024

Workshop 2 - Preparation process authorisation

Schedule: 5, 6, 7 June 2024

Workshop 3 - Biovigilance and hemovigilance

Schedule: 3, 4, 5 July 2024