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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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.

Why is a potency assay important for cell and gene therapy products?

Paula Salmikangas, Björn Carlsson, Christophe Klumb and Tatiana Reimer together with Prof. Steffen Thirstrup published an article in Frontiers in Medicine, Regulatory Science.

Releasing the potential of patient and public perspective

This article, co-authored by Dr Lisa Campbell, Medical Advisor at NDA highlights a number of patient and public involvement and engagement (PPIE) initiatives by regulatory agencies and regulatory science centres.

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

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.

Translational Research

This article explains the crucial steps you need to take to translate basic science into clinical practice.