VCLS authors a number of articles on key industry journals, such as TOPRA Regulatory Rapporteur, Regulatory Focus from RAPS.
Latest Publications
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Reconstruction skin-bone cartliage
Research in the Rhone area is particularly developed in academic laboratories, hospitals with people of international reputation working on dermatologic…
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The challenge of regulating human tissue-engineered products in the EU
Anne Dupraz Poiseau, Anne Virginie and Stuart Mudge report on efforts to create legal definitions for human tissue-engineered and cell…
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Consulting with EU experts Why, When & How
Despite the increasing range of guidance documents available, and the best efforts of those involved in producing them, product development…
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RAPS Orphan Medicinal Products Regulation in Europe
Regulation (EC) No. 141/2000 1 of the European Parliament and of the Council on Orphan Medicinal Products was drafted on…
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The need for a Human Tissue Engineering Product Regulatory Framework in Europe
Technical advancements in molecular and cellular biology have the potential to provide an amazing array of human tissue engineering products…
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Biotech Clinical Development in European Union Anticipating the regulatory hurdles
With the exponential growth in biotechnology product development, it follows that there is a corresponding increase in biotech clinical trial…
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Cell Therapy – Current Regulatory Framework,Forum article for April 2003
Cell therapy consists of the prevention or treatment of human diseases by the administration of viable cells which have been…
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Progress in the development of Regulations for Orphan Drugs in Europe,Forum article for December 2002
Innovative therapies pose special problems for drug developers and regulators alike. By definition, such therapies tend to leap forward into…
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