IFAPP – WEBINAR: EU-CTR UPDATE WORKSHOP

Publicado el 12-06-2024, en Acuerdos, Comunicación, Comunicados, Cursos, Directores Médicos, Eventos y Jornadas, Formación, IFAPP Today, Publicaciones, Socios, Uncategorized, Webinar

Only 6 months left for transition!

Date: 27 June 2024

Time: 12:00 – 02: PM CEST

The “Clinical Trials Regulation”, Regulation EU 536/2014, has been valid since 31 January 2022 and mandatory since 31 January 2023. The “Transition Period” will end on 30 January 2025.

Practical experience of competent authorities and sponsors have detected deficiencies and gaps when applying for authorisation, authorising, supervising and reporting clinical trials in CTIS, the overarching Clinical Trials Information.

• Introduction to new developments in the CTR framework. Dr. INGRID KLINGMANN. Moderator.

• What has changed in CTIS (since March 2023) from EMA’s perspective? OSKIA BUENO ZARAGUETA. Speaker.

• Experience with working in CTIS, relevant changes and requirements for the sponsor. NICOLE WOIK. Speaker

Time Schedule

06:00 – 08:00 AM EST

10:00 – 12:00 AM GMT

12:00 – 02:00 PM CEST

07:00 – 09:00 PM JST

REGISTER in advance for this webinar:

https://us02web.zoom.us/webinar/register/WN_U9r-DCsfQIu5EhfxfhViEA

After registering, you will receive a confirmation email containing information about joining the webinar.