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Observations of a market access expert

An insightful interview with NDA’s Claes Buxfeldt, HTA Director, entitled “Observations of a market access expert” featured in Aprils edition of Pharmafocus.

| Health Technology Assessment, Homepage News, News

Europe vs USA: new drug product approvals in 2018

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.

| Homepage News, Presentations and Infographics

Design and optimisation of a quality target product profile for ATMPs

NDAs Paula Salmikangas discusses how the Quality Target Product Profile (QTPP) can be put to best use when developing ATMP’s.

| Homepage News, Translational Science

Rare Diseases and FDA Advisory Committees: Be the Experts in the Room

NDAs Neelu Agrawal describes the unique challenges, along with key factors for success when preparing for an advisory committee for a rare disease.

| High-stakes Meeting Preparation, Homepage News

Effective presentation of immunogenicity related data in regulatory dossiers

NDAs Paul Chamberlain provides practical advice about how to present immunogenicity-related information in regulatory dossiers in the latest publication of Bioanalysis.

| Homepage News, Library News, News, Translational Science

A New Oncology Era

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.

| Homepage News, Library News

Healthcare White Paper published

On Thursday 4th October, at the prestigious Royal Society of Medicine in London, the Chartered Institute of Ergonomics & Human Factors (CIEHF), launched their much-awaited White Paper setting out CIEHF's vision for the integration of Human Factors in Health & Social Care.

| Community News, Homepage News, White Papers

How to commercialise ATMPs in the EU

This article, written by two of our experts, addresses recent findings from the EMA PRIME scheme and provides information about procedural updates and evolving guidance in the ATMP area.

| Homepage News, News

Regulatory authorities expand their contribution to successful drug development

NDAs Eva Lilienberg details the levels of support pharmaceutical companies can expect to receive from the authorities and how to best prepare for any agency interactions in the latest SwedenBio’s fact sheet.

| Homepage News

Regulatory strategies for value maximisation of early clinical stage assets

Prepare for partnering – Optimizing value in early development.

| Homepage News

Pdf - Seeking Parallel Consultation

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Seeking Parallel Consultation

Learn about the rationales and results of engaging early with regulators and HTA bodies in this white paper written by NDAs Dr. Mira Pavlovic-Ganascia and Claes Buxfeldt.

| Community News, Health Technology Assessment, Homepage News, Library News, News, Services News, Social News

Europe vs USA: new drug product approvals in 2017

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.

| Community News, Homepage News, Library News, News, Presentations and Infographics, Services News, Social News

Assessing the consequences of the EMA's relocation

The EMA is relocating to Amsterdam – but what are the consequences to the Agency’s priorities and to the industry?

| Community News, Library News, News, Services News

Revamping Regulations

| Library News, Translational Science

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