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.
24-03-2021

Addressing the challenges of GTMPs

Dr Paula Salmikangas and Dr Björn Carlsson address the challenges related to the development of novel gene therapies.
25-02-2021

Starting out with the end in mind

Since 2009, Paul Chamberlain has pioneered the submission of a multidisciplinary section of the CTD format to provide regulatory assessors with an extended data analysis.
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
23-09-2020

Integrated product development for ATMPs

In this article, published in the September issue of MedNous, Claes and Paula discuss why an integrated product development strategy for ATMPs is essential to meet both regulatory and HTA requirements.