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What makes NDAs new General Manager for the Nordics, Robert Kronqvist, tick?
Earlier this year the 2nd International Alliance of Biological Science meeting was held to review the status of the current knowledge regarding the relationship between narcolepsy and the administration of the adjuvanted pandemic influenza vaccines.
In this commentary, NDA's Johan Strömquist and Thomas Lönngren provide their reflections on the unique opportunities the Nordics present for the Life Science sector.
In this white paper, Steffen and Eva discuss the different tools available to European regulators and the experiences so far with the PRIME pathway.
In this article, NDA's Steffen Thirstrup discusses three important factors to help you prepare for high stakes meetings with EU Regulators.
In this white paper, PharmApprove's Lisa Peluso discusses how excellent communications are the backbone of streamlined, efficient programs achieving approval and market access.
NDA’s Dr Mira Pavlovic-Ganascia and Claes Buxfeldt provide insight on what the expected outcomes of constructively engaging with regulators and HTA bodies could be.
Business Sweden, together with SwedenBIO, have outlined the current state of Swedish orphan development in a new report. It describes a vibrant drug development landscape that is reflective of the global move towards orphan development and the strong emphasis on oncology.
In this white paper NDA's CEO, Johan Strömquist, discusses four ways that Health Technology Assessments will change under the new proposed European regulation.
An insightful interview with NDA’s Claes Buxfeldt, HTA Director, entitled “Observations of a market access expert” featured in Aprils edition of Pharmafocus.
What are the key differences in new drug product approvals across the US and EU regions? Learn about the state of drug approvals in the world's two largest markets.
NDAs Paula Salmikangas discusses how the Quality Target Product Profile (QTPP) can be put to best use when developing ATMP’s.
NDAs Neelu Agrawal describes the unique challenges, along with key factors for success when preparing for an advisory committee for a rare disease.
NDAs Paul Chamberlain provides practical advice about how to present immunogenicity-related information in regulatory dossiers in the latest publication of Bioanalysis.
In this article written by Dr Terese Johansson, Regulatory Consultant, you can read about how recent developments in tumourigenesis genomics have paved the way for a molecular marker defining a disease that spans multiple histology-based tumours in a tissue-agnostic manner.
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