Project Management and Monitoring – Winter Course 2024
🔔 We offer information directly from practice!
The regular two-day seminar PROJECT MANAGEMENT AND MONITORING is organized in cooperation with St. Anne’s University Hospital Brno (FNUSA) – St. Anne’s University Hospital Brno / FNUSA-ICRC.
The workshop is intended for all those who want to work in clinical trials: study nurses, clinical trial coordinators, monitors and project managers, especially from academic and non-profit organizations.
The event is realized with the organizational support of the Pharmaround Foundation and is guaranteed by ČAS – Czech Nurses Association.
Both days are complemented by practical exercises where you can easily verify all the acquired knowledge under professional supervision.
FRAMEWORK PROGRAMME OF THE SEMINAR
December 2024
PROJECT MANAGEMENT
🔹 Project Management and Clinical Trial Legislation
🔹 CTIS portal and preparation of documents for submission – initial submission, amendments, transfer
🔹 Report submission during and after clinical trial
🔹 Preparation of documentation for data management, communication with project manager and monitor, data export
🔹 Pharmacovigilance
🔹 Practical exercises
December 2024
MONITORING
🔹 General introduction to monitoring in clinical trials
🔹 Monitoring manual, CAPA
🔹 Monitoring issues – practical experience
🔹 SÚKL inspection
🔹 Implementation of First in Human studies from the centre’s perspective
🔹 Practical exercises
Register early!
Registration form: https://lnkd.in/e8wzJd3u
