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Project Orbis: How Trans-Jurisdiction Review Is Accelerating Global Product Launches

Project Orbis is a great opportunity for enhanced collaboration between regulatory agencies across the world which has resulted in substantially expeditious approvals of medicines.

| Homepage News, Library News, Oncology, Regulatory Affairs

The Road to Pharmacovigilance Outsourcing Guidance

Looking for Pharmacovigilance support? Learn how to make the process as easy as possible with these step by step guidelines to outsourcing pharmacovigilance services.

| Homepage News, Library News, Pharmacovigilance, Regulatory Affairs

Expedited Reviews: What you need to know to be Successful

This case study is an excellent example of how a well-planned and meticulously executed regulatory strategy can lead to a collaborative and rapid review

| Homepage News, Library News, News, Regulatory Affairs, Services News

Remote audits – The new normal

In this whitepaper, we will provide tips and good practices for remote audits as an alternative method to conducting traditional on-site audit.

| Homepage News, Quality, Services News, White Papers

Integrated product development for ATMPs

Claes Buxfeldt and Paula Salmikangas discuss why an integrated product development strategy for ATMPs is essential to meet both regulatory and HTA requirements.

| Health Technology Assessment, Homepage News, HTA Advisory Board, Services News, Translational Science

Market access for immune-oncology products in the EU

Claes Buxfeldt discusses key considerations in early development to succeed with market access for immune-oncology products in the EU.

| Health Technology Assessment, Homepage News, HTA Advisory Board, Services News

The challenges to overcome age-related disease

In this article, Tom Hughes and Johan Strömquist discuss the challenges facing longevity research and the adoption of health span as a viable target for medicines in the future.

| Homepage News, Library News, News, Regulatory Advisory Board, Services News

Enhancing Pharmacovigilance

In this article, Dr Brian Edwards follows on from his very successful webinar, Opportunities to enhance Pharmacovigilance in Oncology, to argue that to maximise the benefits of innovation in our products we need innovative pharmacovigilance.

| Homepage News, Library News, News, Oncology, Pharmacovigilance, Regulatory Advisory Board, Services News

Potential Consequences of SARS-CoV-2 to ongoing clinical programs

In this white paper, NDA's Laurie Smaldone discusses the potential impact of COVID-19 on on-going clinical trials.

| Homepage News, Leadership Team, Library News, News, Regulatory Advisory Board, Regulatory Affairs, White Papers

What did we learn from the 2009 pandemic?

In this commentary, NDA's Thomas Lönngren discusses the regulatory learnings from the 2009 pandemic and how these are applicable to the current pandemic.

| Advisory Services, Homepage News, Infections and Infectious diseases, Library News, News, Regulatory Advisory Board, Vaccines

Medical Devices and their growing regulatory challenges

In this article, NDA's Tina Amini explains what companies need to look out for in the growing area of device regulation.

| Homepage News, Library News, News, Services News

NDA Medical Device Division launched

We are proud to announce the creation of a new division within NDA, focusing on advice and support to companies facing increasing regulatory challenges in the device space.

| Homepage News, News, Services News

Hopes and challenges in the future of the immuno-oncology field

There is no doubt that the area of oncology development has exploded in the last few years.

| Homepage News, Oncology

The future of NDA in the Nordics

What makes NDAs new General Manager for the Nordics, Robert Kronqvist, tick?

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

What do we need to know before the next influenza pandemic?

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.

| Community News, Homepage News, News, Services News, Vaccines

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