Thought Leadership
At NDA our experts stay abreast with the evolving environment and the new regulatory requirements that it gives rise to. One of the results of these activities is a stream of articles, commentaries and white papers that we publish for the benefit of our clients and followers. It captures the state of the art of our industry today.
We call it Thought Leadership.
Articles and White Papers
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18-10-2023
The role of real-world evidence in regulatory decision making: Current use and future potential
In this webinar, Dr Chantal van Gils, Director of Epidemiology and Real-World Evidence for the NDA Advisory Board, discusses the growing role of real-world evidence in regulatory decision making.
09-05-2023
Project Optimus – A Reform in the Dose Optimization and Selection in Oncology Drug Development
In this white paper, Dr Laurie Smaldone Alsup, Chief Medical & Scientific Officer at NDA, explores the goals of Project Optimus and how it can impact time to approval.
30-03-2023
Target Product Profile (TPP)
This guide will help you create one of the most crucial documents you'll need in your drug development journey: The Target Product Profile.
29-03-2023
Unmet Medical Need: A Regulatory Perspective
In this webinar, Jan Sjöberg discusses the regulatory perspective of unmet medical need as a key criterion for drug development, based on his experience as an former EU regulator.
08-02-2023
Going Faster – How Project Orbis and ACCESS Consortium Expedite Cross-Jurisdictional Approvals
In this white paper, Ricarda Meincke provides guidance if you are considering parallel submissions in several jurisdictions for your product.
06-10-2021
NDA Webinar: Optimise your interactions with European Regulatory Agencies
In this webinar Dr Roz Cox discusses the opportunities for interacting with European Regulatory Agencies, and how to optimise these interactions