IFAPP – WEBINAR: EU – CTR UPDATE WORKSHOP

Publicado el 21-06-2024, en Acceso al Mercado, Acuerdos, Comunicación, Comunicados, Directores Médicos, Enfermedades Raras, Entrevistas, Estrategia y Operaciones, Eventos y Jornadas, Farmacovigilancia, Farmacovigilancia (FV), Formación, Formación Universidades, Grupos de Trabajo, IFAPP Today, Información Médica, Información Médica (IM), Investigación Clínica, Market Access, Medical Liaison (MSL), Medicina de Precisión, Medicina de Precisión, MSL, Noticias AMIFE, Noticias Generales, Patient Centricity, Publicaciones, Socios, Uncategorized, Webinar

Only 6 months left for transition!

Date: 27 June 2024

Time: 12:00 – 02:00 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.

Moderator

DR. INGRID KLINGMANN. Introduction to new developments in the CTR framwork

Speakers

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

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

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.

TIME SCHEDULE

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