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
Service:
Scientific:
Sort by:
All services
Development Strategy
Medical Devices
Pharmacovigilance
NDA Advisory Board
Strategic Communications
Regulatory
Quality & Compliance
All expertise
Oncology
Vaccine
Immunogenicity
HTA
In-Vitro Diagnostics
Non-Clinical
Cell and Gene Therapy
Biostatistics
Cardiology
ATMP
Rare Disease
Market Access
CMC
Clinical
Paediatric
Acceleration Strategies
Medical Devices
Quality
Patient Safety
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.
13-10-2021
A new dawn in Regulation and Access
Scientific Writer, Ingela Loell, provides insight into ILAP and the collaborations providing quicker approval and patient access.
04-06-2021
Patient Access in the real world: Addressing challenges and opportunities.
NDA Advisory Board Members, Mel Walker and Yngve Mikkelsen provide an insight into how global events can impact patient access in a real-world setting.
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.
01-09-2020
Market access for immune-oncology products in the EU
In this article, published in Volume 22 September 2020 of Pharmafocus, Claes Buxfeldt discusses key considerations in early development to succeed with market access for immune-oncology products in the EU.