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

Advanced therapies in the EU :speedy adoption or beleaguered by questions?


The industry is caught between wanting numerous questions answered on the text and a rapid implementation of new rules to end the current fragmented regulatory "nightmare" that currently exists in Europe.

The pros and cons of the Commission’s proposal for Advanced Therapy Products


The European Commission’s proposal for a Regulation on Advanced Therapy Medicinal Products (ATPs) is a significant step towards EU-wide harmonization, clarity and certainty for tissue engineered products. But the new clarity comes at a significant cost to the medical devices industry.

Regulatory Advanced Therapies in the EU: a square Peg in a round hole

Informa UK Ltd

Anne Dupraz Poiseau and Stuart Mudge examine the European Commission's proposal for a regulatory framework for human tissue engineered products.

Pathways and Strategies for combination products in the EU

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

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.