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Publications
We author publications presenting our opinions, methodological approaches to health
products development, and our views on environment changes.

Development of orphan products and the impact of the EU Paediatric Regulation ,TOPRA Vol 9, No.10

2012
Regulatory Rapporteur

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 OMPs.

Quality by design: a beginner’s guide

2012
STP Pharma Pratiques

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.

Nutraceuticals and functional food regulations in key emerging markets Part I ,TOPRA Vol 9, No.5

2012
Regulatory Rapporteur

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 products have increasingly experienced more stringent regulatory controls for the primary reasons of product safety, public health and consumer protection.

Applying for multinational EU Trials can be faster via voluntary harmonisation procedure

2012
SCRIP Regulatory Affairs

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.

US&EU Regulations for drug delivery systems: development considerations for innovate products

2012
SCRIP Regulatory Affairs

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.

Hybrid or Mixed Marketing Authorization Application in the EU: not a trivial decision in new development programs for established drugs

2012
Drug Information Journal

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 exclusivity, and the pediatric requirements in a significant way.

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