Critical Timelines for EU CTR Implementation - Are you prepared?
December 5, 2024
30 Minutes
Join the Webinar at your Convenient Time
For AMR & EUA
10:00 AM EST |3:00 PM GMT |4:00 PM CET
For RoW
11:30 AM IST
What is it all about?
The EU Clinical Trials Regulation (EU CTR) is replacing the EU Clinical Trial Directive (EU CTD) with an official implementation date of 30th January 2025.
The Clinical Trials Information System (CTIS) is the centralized EU database of the EU CTR. It allows sponsors to submit a single application for clinical trials across multiple countries. A centralized approach benefits patients and healthcare professionals, and promotes scientific collaborations. This approach across the EU region would also ensure strategic alignment between sponsors within the EU and the EEA regions, while reducing the duplication of clinical research efforts.
This webinar aims at summarising the changes to the procedures and highlights critical points to address, before submitting a Clinical Trial Application using the EU CTIS portal.
Neha is a Chemist by training and has over twelve years of experience working in the Analytical and Clinical Science research laboratories. She has led various scientific operations and marketing projects in the pharma and consumer delivery segments. Neha has worked on multiple projects with various Regulatory agencies and has supported companies seeking Regulatory compliance in the US and EU markets.
Neha is currently working as a Project Manager and Regulatory Consultant for multiple projects at Freyr Solutions. She also supports Freyr’s Medical Writing and Communications domain as well as their marketing initiatives.
Alessandra Panico is the Senior Manager who works on the Medicinal Products Review (MPR) projects within Freyr Solutions. She focuses on Clinical Trial Application (CTA) projects in the EU and Non-EU regions. Alessandra leads a team that manages the CTA workstream for the Freyr EU site.
With over 15 years of experience in the Regulatory Affairs space, she enjoys helping companies tailor strategies and solutions. Alessandra is a seasoned expert on the EU CTA system and the EU CTIS portal for making clinical trials submissions.