SME and academia Clinical Trials Information System (CTIS) two-part training webinar - Day 2

• Date:
  Thursday, 4 March 2021, All day
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This training webinar provides essential information on  CTIS for micro, small and medium-sized enterprises (SMEs) and non-commercial (academic) sponsors. For more information on CTIS, see Clinical Trial Regulation.

This is the second day of a two-day webinar. It will cover:

• Submitting an initial trial application in CTIS
• Updating an initial trial application, including making substantial modifications and adding a Member State concerned
• Making non-substantial modifications
• Submitting trial results

Presentations are provided by EMA system experts, European Commission, and presenters from SME and academic institutions. These will be complemented by pre-recorded demonstrations of the system.

The first day of the webinar is on 22 February 2021. EMA advises participants to attend both days of this training webinar. 

The webinar is free of charge for all attendees.

Documents

Agenda - SME and Academia Clinical Trials Information System (CTIS) two-part training webinar

Adopted

Speaker bios - SME and Academia Clinical Trials Information System (CTIS) two-part training webinar

Reference Number: EMA/102023/2021

Answers to knowledge check in the post event survey - SME and Academia Clinical Trials Information System (CTIS) two-part training webinar

Presentation - Sponsor activities during the life cycle of a clinical trial: submission of notifications (Stéphanie Kromar)

Presentation - Submission of an initial Clinical Trial Application in CTIS – structure, data and documents of an initial application dossier (Laura Pioppo)

Presentation - Submission of trial results and layperson summary (Andrea Seidel Glätzer)

Presentation - Transparency publication of clinical trial information contained in CTIS (Laura Pioppo)

Presentation - Changes done to an application via NON SM and RFI responses (Laura Pioppo)

Presentation - Update of an initial application (Laura Pioppo)

Presentation - Work planning and management tools (Stéphanie Kromar)

Multimedia