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.
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.
02-12-2020
Expedited regulatory pathways: EU and US approaches
What you have and what you want decides which tool to use – insights into the expedited regulatory pathways in the EU and US
20-01-2019
European Regulatory Meetings – how best to prepare and perform
In this article, Dr Steffen Thirstrup discusses three important factors to help you prepare for high stakes meetings with EU Regulators.