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



Sort by:


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.

Understanding why the Patient Holds the Key to Successful Drug Development

In this whitepaper, Dr Lisa Campbell, Senior Consultant & Medical Advisor at NDA, explores the benefits and challenges of ensuring patient experiences and priorities to define success

Ensuring Quality and Compliance: Foundational Principles for Drug Development

In this whitepaper, Helen Kargaryani, Global Head of Quality at NDA outlines foundational principles for regulatory compliance, emphasizing Quality Management Systems and Good Manufacturing Practices

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.

What’s new in PRIME?

In this white paper, Dr Jan Sjöberg, Medical Advisor & NDA Advisory Board Member, and Dr Ingela Loell, Scientific Writer & Editor at NDA Group, explore the latest advancements in PRIME

Single-Arm Trials in Oncology: Key Insights from the Latest EMA and FDA Guidance

This white paper written by Adriana Andrić, Senior Consultant at NDA Group, explores the regulatory guidance considerations in relation to the design, planning, conduct, analysis, and interpretation of results derived from SATs.