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Global capabilities for local growth

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.

| Articles, Events & Presentations, Homepage News, Leadership Team, News, Social News

Prime - The European approach to expedited pathways

In this white paper, Steffen and Eva discuss the different tools available to European regulators and the experiences so far with the PRIME pathway.

| Articles, Homepage News, News, Pre-submission, Regulatory Advisory Board, White Papers

European Regulatory Meetings - how best to prepare and perform

In this article, NDA's Steffen Thirstrup discusses three important factors to help you prepare for high stakes meetings with EU Regulators.

| Articles, High-stakes Meeting Preparation, Homepage News, News, Regulatory Advisory Board

Importance of Excellence in Scientific and regulatory Communication

In this white paper, PharmApprove's Lisa Peluso discusses how  excellent communications are  the backbone of streamlined, efficient programs achieving approval and market access.

| Articles, High-stakes Meeting Preparation, Homepage News, News, Pharmapprove, White Papers

Why should you engage early with regulators and HTA bodies?

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.

| Articles, Health Technology Assessment, Homepage News, News, White Papers

4 ways that HTA will change under the new European regulation

In this white paper NDA's CEO, Johan Strömquist, discusses four ways that Health Technology Assessments will change under the new proposed European regulation.

| Articles, Health Technology Assessment, Homepage News, News, White Papers

Webinar - Is an Early Development Strategy Really Needed?

Join us on 16th May at 15:00 BST, 16:00 CEST, 10:00 EDT for this engaging webinar with Dr Niamh Kinsella, Biologics Expert, VP, Early Stage Development.

| Homepage News, 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.

| Articles, Homepage News, News, Translational Science

Free Webinar - Brexit Impact: Are you ready?

Join us on Thursday 14th February for this engaging webinar with Thomas Lönngren, Strategic Advisor and Dr Brian Edwards, Principal Consultant about Brexit impact.

| Homepage News, News, Presentations and Infographics

NDA Group expands presence in Denmark

In time for the European BIO meeting in Copenhagen NDA is expanding the physical presence in Denmark. With the appointment of Katja Gustafsson as Senior Consultant NDA will be working closely with clients in the region.

| Community News, Homepage News, News, Services News, Social News

Recommendations from PRAC – Insights and implementation

NDA invites to breakfast seminar where Shelley Gandhi speaks on recommendations from PRAC - insights and implementation.

| Community News, Homepage News, Social News

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.

| Articles, Homepage News

Meet NDA at DIA European Forum for Qualified Person for Pharmacovigilance (QPPV)

NDA's Helen Powell & Brian Edwards have been invited to chair two Sessions at DIA European Forum for Qualified Person for Pharmacovigilance (QPPV), London, 10-11 October 2018

| Community News, Homepage News, News, Pharmacovigilance, Presentations and Infographics, Services News

Paula Salmikangas presents on Regulatory and scientific challenges for global development

NDAs Dr Paula Salmikangas has been invited to present at the World Advanced Therapies and Regenerative Medicine Congress.

| Community News, Homepage News, News, Services News, Social News

Free Webinar - Rational EU risk management for oncology medicines: time for a rethink

Join us on Thursday, 24th May to learn how you can implement the revised GVP module (V) concerning risk management in the interests of patients throughout the life-cycle of a medicine.

| Community News, Homepage News, News, Services News, Social News

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