Stricter rules are in store for CDx stakeholders in the EU but it’s not all bad news.

Sylvie Le Glédic, Sabah Malek

2013 - SCRIP Regulatory Affairs

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Valerie Pimpaneau and Anne Dupraz Poiseau discuss the latest EU guidelines on ATMPs and explain how to develop a solid chemistry, manufacturing and control strategy for such products.

Valérie Pimpanneau, Anne Dupraz-Poiseau

2012 - SCRIP Regulatory...

Development of orphan medicinal products (OMPs) is challenging by nature: knowledge is usually limited; the patient population are small and often frail; and the implementation of the Paediatric Regulation in the EU has added a layer of complexity, especially for...

Quality by design (QbD) is becoming increasingly utilized as a valuable tool for focused and efficient drug development. Centering on case studies, we will look at how QbD can be used in its application to small molecules and biopharmaceuticals.

Florence...

Nutritionals & Nutraceuticals describe the group of products occupying the grey zone between food and medicines and having recognisable health and physiological benefits attributable to the efficacy of their consumption. In the more developed markets, these...

Using the voluntary harmonisation procedure to apply for permission to conduct multinational clinical trials across the EU can, in some cases, lead to faster trial authorisations, compared with using the traditional application approach.

Neena Brizmohun,...

Marielle Fournier and Anne Dupraz-Poiseau describe US and EU rules governing prefilled syringes, pen injectors and innovative drug-delivery systems for biologics and consider the safety, quality and efficacy development challenges for manufacturers.

Anne...

For any medicinal product Marketing Authorization Application (MAA) in the European Union, the applicant needs to indicate the legal basis for the application. This legal basis, laid down in Directive 2001/83/EC as amended, determines the dossier content, the market...

Biomarker qualification can be a first step towards companion diagnostic development. The European Medicines Agency already has a biomarker qualification process and the US Food and Drug Administration is developing one itself. The two agencies should find a way to...

In Europe, advanced therapy medicinal products (ATMPs) are subject to the requirements laid down in the Paediatric Regulation. A company developing an ATMP must, therefore, obtain agreement from the EMA on a paediatric investigation plan (PIP) or waiver prior to...

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