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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12-01-2024
Joint Scientific Consultations – Advice for EU Health Technology Assessment
This white paper authored by NDA Advisory Board member, Dr Sigrid Klaar, provides valuable details around the Joint Scientific Consultations.
29-05-2023
Joint Clinical Assessments – Mandatory EU-Level Evaluations for Health Technology Assessment
This white paper authored by NDA Advisory Board member Sigrid Klaar, provides a comprehensive overview of the JCA procedure for medicines.
17-05-2023
Regulatory framework for real-world data progresses
In the November / December issue of MedNous, Dr Chantal van Gils, Director of Epidemiology and Real-World Evidence, provides some insights into the regulatory framework for real-world data progress
08-12-2021
The outlook for gene editing in treating disease
Dr Paula Salmikangas, Dr Björn Carlsson and Dr Steffen Thirstrup address the risks and challenges of gene editing.
29-11-2021
Oral explanation – Your product’s last stand
In this article, we provide insight into oral explanations and what you need to emphasize in a presentation in order to engage with EU regulators.
20-10-2021
Controlled Human Infection Studies
NDA's Dr Paula Salmikangas and Dr Pieter Neels co-wrote and shared their knowledge in this insightful article that was published on the 4th of October in Biologicals.