Clinical Trials Information System (CTIS) bitesize talk: Initial clinical trial application, from 23/03/2022 to 23/03/2022

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EMA Events

Guest
This bitesize talk on CTIS provides an opportunity for sponsors to learn about initial clinical trial applications. It covers:

  • the data and documents required for an application;
  • how to create, submit, cancel or withdraw an application.

The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations.

The Clinical Trials Information System (CTIS) will act as a single entry point for clinical trial authorisation and supervision in the European Economic Area. CTIS is the business tool of the EU Clinical Trials Regulation (Regulation (EU) No 536/2014).

EMA cannot provide attendees certificates of attendance for this event.

A video recording is made available after the event.

Sumber : https://www.ema.europa.eu
 
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