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EMA offers a virtual training programme, organised by DIA, to support sponsor user preparedness for the new Clinical Trials Information System and the new way of submitting a clinical trial application and managing the life cycle of a clinical trial in the European Union (EU) and European Economic Area (EEA).
A blended learning approach will be used, offering on-demand components, as well as live virtual instructor-led offerings.
On-demand components, which must be completed before accessing the live offering, include:
Key topics covered during the live virtual offering include:
This event is aimed at sponsor users of the Clinical Trials Information System.
Six separate courses are currently planned throughout 2022. The course dates are below:
Sumber : https://www.ema.europa.eu
A blended learning approach will be used, offering on-demand components, as well as live virtual instructor-led offerings.
On-demand components, which must be completed before accessing the live offering, include:
- Introduction to Clinical Trials Regulation (CTR) (EU) No 536/2014
- Transparency
- Data protection in CTIS
- CTIS Sponsor User Personas
Key topics covered during the live virtual offering include:
- Overview of CTIS components and system functionalities
- Sponsor User Access Management
- Management of registered users (Role Matrix)
- Workload management. Work-planning and management tools
- Create, submit and withdraw an initial application; Update initial application through other applications (substantial modifications, additional MSC)
- Respond to Request for Information (RFI) received during the evaluation
- Manage a Clinical Trial through CTIS
- Sponsor search, view and download a Clinical Trial and Clinical Trial Application (CTA)
- Create and submit an Annual Safety Report and respond to related RFIs
- Clinical Study Reports (CSR) submissions
This event is aimed at sponsor users of the Clinical Trials Information System.
Six separate courses are currently planned throughout 2022. The course dates are below:
- 24 - 27 January 2022 | 14:00 - 18:30 Amsterdam time (CET)
- 15 - 18 February 2022 | 09:00 - 13:30 Amsterdam time (CET)
- 01 - 04 March 2022 | 09 :00 - 13 :30 Amsterdam time (CET)
- 05 - 08 April 2022 | 14 :00 - 18 :30 Amsterdam time (CEST)
- 10 - 13 May 2022 | 09 :00 - 13 :30 Amsterdam time (CEST)
- 20 - 23 June 2022 | 14 :00 - 18 :30 Amsterdam time (CEST)
Sumber : https://www.ema.europa.eu