Markéta Salačová May 20, 2024 | 0

Project management and monitoring 2024

St. Anne's University Hospital in Brno

June 6 and 7, 2024

Project management and monitoring 2024

The popular seminar PROJECT MANAGEMENT AND MONITORING has been organized in cooperation with FNUSA and ČAS for several years now and is always very quickly filled up because it is packed with practical information and experience of trainers who are involved in clinical evaluations on a daily basis.

6 June 2024 | 9:30-17:00
7 June 2024 | 9:30-16:00

6 June 2024 | 9:30-17:00

Project Management

Clinical trial legislation, project management in academic settings and sponsor responsibilities
CTIS portal and preparation of submission documents
Pharmaceutical documentation (SmPC and IPLP), including supplementary documentation for initial submission
Reporting during and after the clinical trial
Preparation of documentation for data management, communication with project manager and monitor, data exports
Basic pharmacovigilance concepts and regular reporting to the authority
Practical exercises

7 June 2024 | 9:30-16:00

Monitoring

General introduction to monitoring in clinical trials
Initial and final visit
Ongoing monitoring – on-site, remote and centre support
Panel discussion of the KH implementation experience from the perspective of the monitor and project manager
Monitoring from the perspective of the centre
Practical exercises

This two-day, information-packed workshop is designed for all those interested in working in clinical trials: study nurses, KH coordinators, monitors and project managers, from both academic and non-profit organisations.

The workshop is free of charge, but travel/accommodation costs are covered by the participant.

Registration is only possible through the registration form.

The event is implemented with the organizational support of the PharmAround Foundation and is sponsored by the Czech Nurses Association.