Developing a winning regulatory strategy for Orphan Designation across the EU, USA and APAC.
Category - Pharmaceutical & biotechnology regulatory consulting & services
Overview of the Orphan Designations Webinar
This webinar is divided into several sections, either focusing on different aspects of orphan designation (OD) in key global markets or rare disease trials. The goal is to provide attendees with a comprehensive understanding of the benefits, application processes, and strategic implications of securing orphan designations globally.
Transitioning to the Clinical Trials Regulation 536/2014 (CTR) – Key considerations
Transitioning studies approved under the Clinical Trials Directive 2001/20/EC (CTD) to the new Clinical Trials Regulation 536/2014 (CTR) is a common challenge for sponsors. This blog will provide an overview of how to transition a study to the CTR and some key considerations.
Webinar: Verify your clinical study design with regulators & manage your vendors efficiently
In this webinar we focus on the optimization of scientific clinical plans, clinical vendor management and contracting. With rapidly changing standards of care, the appropriate clinical study design can be a moving target.
First experience with CTIS – Interview with Heike Schön
We sat down with Heike Schön our CEO to discuss how our clients can remain inspection ready this year, Clinical Trials Information System (CTIS) and to find out what Lumis have in store for 2023!