About

Since 31 January 2023, the EU Clinical Trials Regulation No. 536/2014 (EU CTR) became mandatory for initial clinical trial applications in the EEA. These applications now have to be submitted through the Clinical Trials Information System (CTIS). The new requirements introduced by the EU CTR, coupled with the complex functionalities of the new portal often pose challenges to applicants, who should be aware of all that entails before working in CTIS.

The aim of this interactive demo is to help sponsors and CRO organisations navigate through the complexities of the EU CTR and CTIS, being able to ask questions on the way to ensure a deep understanding.

  • An overview of EU CTR specificities
  • Key aspects of working in CTIS
  • Live demo on initial and transitional clinical trial applications
  • Q&A session
  • Regulatory specialists
  • Clinical Trial Submission specialists
  • Clinical Operations professionals

This seminar will show you how to manage the CTIS portal and prepare you for practical submission work, with a live demo in CTIS Sandbox, based on scenarios that could be encountered in a “real life” setting.

Lecturers
Ruxandra Popescu
Info

Ruxandra Popescu

Manager Regulatory Affairs Europe at Travere Therapeutics

Ruxandra is a pharmacist with over 7 years of experience in Regulatory Affairs and an EMA-certified CTIS Sponsor Master Trainer. In her current role at Travere Therapeutics, she is coordinating the internal EU CTR implementation and advising on clinical trial submission aspects. Prior to joining Travere, Ruxandra worked as Senior Regulatory Scientist at Voisin Consulting Life Sciences, where she was leading clinical trial submissions to Competent Authorities, Ethics Committees and other bodies, in European and non-European countries, also preparing and delivering trainings on the EU CTR and CTIS. During her tenure at the European Medicines Agency, Ruxandra has contributed to the development of the CTIS portal, being involved in user testing.


This online training consists of 1 module:

01 March 2023 from 2:00 pm to 5:30 pm CET

 

After the registration, you will receive all details about the connection.

This course admits a maximum number of 15 participants.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 485,00* until 24/02/2023

Ordinary: € 615,00*

Freelance – Academy – Public Administration**: € 365,00*

* for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Register

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Printable Version
At the end of the training, you will be able to
Risultato atteso
Understand the prerequisites and the key challenges of conducting clinical trials under the EU CTR, with a focus on submissions
Risultato atteso
Become accustomed to the practical process of submitting a clinical trial application via CTIS through a hands-on experience
Risultato atteso
Get clarifications on the questions you wanted to ask about CTIS

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>