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 introduction of the Clinical Trials Information System (CTIS), A centralized EU database portal allows sponsors to submit a single application for multi-country trials. This shall not only benefits patients and healthcare professionals but also promotes scientific collaboration and reduces duplication of clinical research efforts.
Moreover, the EU CTR introduces also introduces the challenges on the sponsors front in terms of operation ability considering the transition deadline.
This evolution could lead to more efficient processes for clinical trials involving well-understood treatments, potentially encouraging more research in these areas but also a need of strategic alignment to the sponsors hosting trials across the EU.
To provide more inputs on these insights and various unanswered questions around EU CTR requirements, Freyr brings you an informative webinar on:
The webinar will be hosted by Neha Ahuja and will be presented by Alessandra Panico. In brief, the topics that will be discussed during the webinar include:
- EU-CTR application and main aspects
- EU CTR Pre-submission and Submissions considerations
- EU-CTR evaluation
- EU-CTR timelines
- Sources & Useful links
Neha is a Chemist by training and has over twelve years of experience working in Analytical and Clinical science laboratories, leading scientific operations, marketing, and consumer delivery segments. She has worked on multiple projects with Regulatory agencies and has supported companies seeking Regulatory compliance in the US and EU markets.
Neha is currently 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 Sr. Manager II handling Medicinal Product, Regulatory Affairs at Freyr. She focuses on Clinical Trial Applications (CTA) projects in EU and Non-EU regions and leads a team who handles CTA workstream in Freyr Poland site. With 15 years of Regulatory affairs domain experience, she enjoys helping companies tailor strategies and solutions. With an intent to bring forth a revolution in the Clinical Trial Application realm, Alessandra will hosts this webinar on CTA system for EU and non-EU region by sharing her CTA and its submissions.