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

Reconstruction skin-bone cartliage

2004
Rhone-Alpes Programme

Research in the Rhone area is particularly developed in academic laboratories, hospitals with people of international reputation working on dermatologic aspects. This led the ARTEB to launch a study on the area of ​​skin reconstruction, and bone cartilage to determine how the Rhône-Alps is compared to France, Europe and the World.

The challenge of regulating human tissue-engineered products in the EU

2004
The Regulatory Affairs Journal

Anne Dupraz Poiseau, Anne Virginie and Stuart Mudge report on efforts to create legal definitions for human tissue-engineered and cell therapy products.

Consulting with EU experts: Why, When & How

2004
ERA news

Despite the increasing range of guidance documents available, and the best efforts of those involved in producing them, product development sponsors are often faced with challenges that require a “case-by-case” and a “scientific-based” approach.

RAPS Orphan Medicinal Products Regulation in Europe

2004
RAPS Book Chapter

Regulation (EC) No. 141/2000 1 of the European Parliament and of the Council on Orphan Medicinal Products was drafted on December 16, 1999 and formally adopted by the European Commission on April 27, 2000. This regulation established a Community procedure for designating orphan medicinal products and introduced incentives for the research,development and marketing of orphan medicinal products in the European Union (EU).

The need for a Human Tissue Engineering Product Regulatory Framework in Europe

2004
The Regulatory Affairs Journal

Technical advancements in molecular and cellular biology have the potential to provide an amazing array of human tissue engineering products (hTEP), and in doing so may revolutionize medical practice. The range of potential applications and the marketing potential for this technology is considerable.

Biotech Clinical Development in European Union : Anticipating the regulatory hurdles

2003
Applied Clinical trials

With the exponential growth in biotechnology product development, it follows that there is a corresponding increase in biotech clinical trial experience. However, despite this increase in experience, biotech clinical development continues to be a challenging exercise, particularly anticipating the regulatory requirements for gaining approval to conduct a trial and later the clinical requirements for marketing approval.

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