EMA Clinical Trials Information System - Sponsor user training programme

Practical, hands-on training course on CTIS system functionalities including the creation and submission of an initial application, respond to RFIs, submitting a substantional modification, search and download options. Participants receive access to the CTIS training environment and will practice basic functionalities during the live training course.

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Agenda

Day 1 Oct 19, 2026

9:00 AM — 1:30 PM

INTRODUCTION TO CTIS AND SYSTEM PREPARATORY STEPS, SPONSOR USER MANAGEMENT AND ROLE MATRIX, INITIAL APPLICATION & PRACTICAL EXERCISES

Day 2 Oct 20, 2026

6:00 AM — 6:30 AM

Welcome and Introduction

9:00 AM — 1:30 PM

INITIAL APPLICATION & PRACTICAL EXERCISES, RESPOND TO RFI

Day 3 Oct 21, 2026

9:00 AM — 1:30 PM

SUBSTANTIAL AND NON-SUBSTANTIAL MODIFICATIONS ADDITIONAL MSC APPLICATION, NOTIFICATIONS AND AD HOC RFIs

Day 4 Oct 22, 2026

9:00 AM — 12:30 PM

CREATE & SUBMIT AN ANNUAL SAFETY REPORT AND RESPOND TO RELATED RFIS, CLINICAL STUDY REPORTS (CSR) SUBMISSIONS, SPONSOR DOWNLOAD OPTIONS, Q&A SESSION

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EMA Clinical Trials Information System - Sponsor user training programme

Agenda

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