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What can be Done to Improve Confidence and Trust in the Safety of the System for Pharmaceutical Products?

Dr. Brian Edwards co-authors article on ‘What can be Done to Improve Confidence and Trust in the Safety of the System for Pharmaceutical Products?’ for Current Drug Safety, 2013 Dr. Brian Edwards was selected to co-author a Special Edition for Current Drug Safety, 2013, addressing ‘What can be Done to Improve Confidence and Trust in …

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Managers ignore PV at their peril

The implementation of Europe’s new pharmacovigilance legislation is currently ongoing, creating ripples as each step forward makes the day-to-day effects more tangible. Since July 2012 a new committee at the European Medicines Agency, the Pharmacovigilance Risk Assessment Committee (PRAC), has started to establish itself as a major influence and stakeholder in the system for regulating …

| Pharmacovigilance

Rosalind Cox comments on new EU Medical Device Legislation

Rosalind Cox, Scientific Advisory at NDA Group, writes an article for the December issue of Regulatory Rapporteur on the new EU Medical Device Legislation. She reviews the key impacts of the proposed legislation, referencing that they are still up for review before gaining EU Parliament agreement. This article was Published in Regulatory Rapporteur – Vol …

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Getting good medicines to patients and keeping them there

In this article, published in Regulatory Rapporteur, September 2012, Thomas Lönngren, strategic advisor to NDA Group reflects on the hurdles to overcome and roadblocks still to be negotiated in Drug development – particularly in measuring the “value” of new medicinal product. We live in a world where it is tougher than ever to get new …

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A structured approach to assessment of product suitability for switch to OTC status in the EU

The EU non-prescription market represented 14.5% of total pharmaceutical sales in 2009, equating to 26,062 million Euros (source AESGP). Estimated figures for 2010 are that the EU market will account for 36% of the global non-prescription market (1). This market deserves consideration for established prescription products in the EU Community and can be accessed via …

| Regulatory Affairs

Medicines for older people and the need to get on track

In this article, published in the February 2013 issue of Regulatory Affairs, Markku Toivonen discusses the need to consider the elderly in global drug development. The reasons for the mis-prescribing in this fast growing population are discussed, highlighting the importance of adequate representation in clinical trials, pre and post authorisations studies. Shortcomings in current regulatory …

| Library News

Biosimilars in the EU - what have we learned so far?

NDA Group Advisory Board member, Steffen Thirstrup, has written an article in Scrip Regulatory Affairs Magazine Sep 2013 on ‘Biosimilars in the EU – what have we learned so far?’ With the EU set to approve its first two biosimilar monoclonal antibodies, Steffen looks back over the past seven years since the first biosimilars were approved …

| Biologics, News, Regulatory Advisory Board, Regulatory Affairs, Services News

Making a success of new drug development

Frustrated with the high rate of new drugs failing to pass the regulatory requirements, Dr Lars-Helge Strömquist founded the NDA Group in 1997. In this article, that was published in the September/October 2011 issue of Pharma Magazine, he describes some of the core reasons for this high failure rate and also some of the solutions to counter …

| Regulatory Affairs

Changing the culture of drug safety

In this commentary, that was published in MedNous May 2012, NDA’s Brian Edwards explains what companies need to know about new EU legislation.

| Pharmacovigilance

Impact of the Paediatric Regulation on existing medicinal products – a review

This article, written by NDAs Jill Challis and published in the Regulatory Rapporteur in October 2011, reviews the impact of the Regulation over the last five years on improving the likelihood for safer and more effective use of existing medicines in children. Children are not simply young adults when it comes to medicines. Factors affecting …

| Paediatrics, Regulatory Affairs

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