Pathways and Strategies for combination products in the EU

2005
The Regulatory Affairs Journal

Determining the regulatory path for a combination product is a difficult task. Even in the USA, which seems to have given the most consideration for and focus on defining and regulating combination products, it still involves much uncertainity.

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

2005
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.

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.

Cell Therapy - Current Regulatory Framework,Forum article for April 2003

2003
DIA

Cell therapy consists of the prevention or treatment of human diseases by the administration of viable cells which have been selected, cultured, often multiplied, and possibly pharmacologically treated or altered outside the body (ex-vivo). This article will present the wide array of different approaches present today in Europe for the regulation of cell therapy products and envision how cell therapy products could be regulated in the near future.

Progress in the development of Regulations for Orphan Drugs in Europe,Forum article for December 2002

2002
DIA

Innovative therapies pose special problems for drug developers and regulators alike. By definition, such therapies tend to leap forward into unregulated or incompletely regulated territory. Orphan drugs often fall into the category of “innovative therapies” and certainly stretch and challenge established regulatory guidelines.

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