Critical Timelines for EU CTR Implementation - Are you prepared?
Topics Covered:
We are delighted to see your interest in Freyr’s Webinar on 'Critical Timelines for EU CTR Implementation – Are you prepared?’ was successfully held on December 05, 2024.
The following topics were discussed:
- EU-CTR application and main aspects
- EU CTR Pre-submission and Submissions considerations
- EU-CTR evaluation
- EU-CTR timelines
As a continuous practice, Freyr intends to organize more webinar sessions related to the Regulatory aspects of Life Sciences. We will be happy to inform you in advance about our next session.
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.