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

Voisin Consulting’s comments on the proposed European Regulation on advanced therapy products issued by the European Commission

European Comission

This document summarizes VCLS’s comments on the Draft Regulation and on the Consultation Paper, published by the European Community on 4 May 2005. They concern the scope of the Regulation, the composition of the Committee for Advanced Therapies, the requirements for a Marketing Authorization and the Incentives.

Clinical Trials in Australia

Australian Biotechnology News

Although the major drug development regions of the world are recognized to be North America, Europe and Japan, continuing growth of the pharmaceutical market into emerging regions is being accompanied by similar growth in clinical trial activity outside the traditional “big three” markets.

Reconstruction skin-bone cartliage

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

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

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

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).