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Considerations for Good Pharmacovigilance Outsourcing

Read about the importance for clients and service providers to understand and discuss each other’s needs to avoid unrealistic expectations often elicited prior to signing a contract.

| Community News, News, Pharmacovigilance

New FDA Guidance: Impact on Clinical Safety Data

This article written by NDA’s Brian Edwards and Olga Björklund explains the best way to stay compliant.

| Community News, News, Pharmacovigilance

Regulatory and HTA - The European dream of integrated requirements

A positive marketing authorisation opinion on its own may no longer guarantee patient access to the product and at acceptable prices. Therefore, over the last 5 to 10 years, since Health Technology Assessment (HTA) as a concept has made its way into the heads of the drug development community, it has become an established practice …

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A Core Dossier – Early planning for Global Success

How can the concept of a Core Dossier encompassing different regional requirements assist in ensuring optimal reach of your product as early as possible? Global drug development is based on the premise that the requirements of all relevant regions can be taken into account when creating your dossier. Some companies may indeed have the money …

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Strategies for Success in Global Development

This article will consider the rationale and benefits of identifying global development and commercialization needs early in the product life-cycle and then discuss some strategies for framing the global development. Careful planning and assessment will permit the needs of the major countries and regions to be incorporated into a single global development program which will …

| Translational Science

Communicating for Approval and Market Access

Learn how you can avoid costly delays along the path to regulatory approval and commercialization in this article written by NDAs Lisa Peluso.

| Community News, Library News, News, Services News, White Papers

Europe Vs USA: new drug product approvals in 2015

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 in this NDA article by Olga Björklund.

| Community News, News, Services News, Social News

Adapting to new clinical trial regulation in EU

NDA's Olga Björklund and Brian Edwards have written a commentary about the EU Clinical Trial Regulation coming into effect by October 2018 at the latest.

| Community News, News

Controversies in Establishing Biosimilarity: Extrapolation of Indications and Global Labeling Practices

NDA Advisory Board member, Paul Chamberlain, has co-authored an article titled “Controversies in Establishing Biosimilarity: Extrapolation of Indications and Global Labeling Practices” that recently was published in BioDrugs. Abstract: The principles of establishing biosimilarity are to demonstrate structural and functional similarity to a reference product using the most discriminatory analytical methods. There is still considerable controversy …

| Community News, News

Managing uncertainties – early dialogue for early market access in Europe

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Immunogenicity: anticipating and avoiding issues for biopharmaceutical development

NDA Advisory Board member, Paul Chamberlain, has just had an article titled Immunogenicity: anticipating and avoiding issues for biopharmaceutical development, published in Drug Target Review.

| Community News, News, Social News, Translational Science

Advances in analytical characterization of biosimilars

Dr. Frits Lekkerkerker, NDA Advisory Board member, has written an article titled “Advances in analytical characterization of biosimilars” that was published in GaBI, Generics and Biosimilars Initiative Volume 4 Issues 3.

| Community News, News

Industry and Academia Partnering to Advance Prevention and Treatment of Alzheimer’s Disease

Dr Markku Toivonen, NDA Scientific Director and Advisory Board member, has written an article titled “Industry and Academia Partnering to Advance Prevention and Treatment of Alzheimer’s Disease” that was published in JCS, Journal for Clinical Studies Volume 7 Issues 4.   According to current evidence, Alzheimer’s disease (AD) is a disease continuum with a 10-20-year …

| Community News, News, Social News

Risk Evaluation and Mitigation Strategies - Feedback from GPvP seminar

Helen Powell, Principal Consultant at NDA Group, has authored an article on behalf of the RQA Good Pharmacovigilance Practice Committee on Risk Evaluation and Mitigation Strategies (REMS) that was recently published in the July edition of the RQA journal QUASAR. The article provides an overview of as to what a REMS is, the requirements and components, …

| Library News, News

Achieving safe and timely access to medicines

This commentary by NDA CEO Johan Strömquist is focusing on what Europe is doing – from a regulatory perspective – to promote access to new medicines and was published in the June issue of MedNous.

| Community News, News, Services News, Social News

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