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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14-12-2023
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
14-11-2023
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
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.
09-05-2023
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.
13-04-2023
Translational Research
This article explains the crucial steps you need to take to translate basic science into clinical practice.
30-03-2023
Target Product Profile (TPP)
This guide will help you create one of the most crucial documents you'll need in your drug development journey: The Target Product Profile.