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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Impact of the New Pharmaceutical Legislation on the Development and Registration of Biological Medicinal Products…
This article reviews the impact of the new pharmaceutical legislation on the development of biotech products. The authors describe in…
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Human Tissues: consultants call for end to EU regulatory confusion
Manufacturers of Human Tissue Engineered Products (HTEPs) need to develop a very strong position paper to put an end to…
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Advanced Therapies in the EU speedy adoption or beleaguered by questions
The industry is caught between wanting numerous questions answered in the text and a rapid implementation of new rules to…
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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,…
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Regulatory Advanced Therapies in the EU a square Peg in a round hole
Anne Dupraz Poiseau and Stuart Mudge examine the European Commission’s proposal for a regulatory framework for human tissue engineered products.
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Pathways and Strategies for Combination Products in the EU
Determining the regulatory path for a combination product is a difficult task. Even in the USA, which seems to have…
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Voisin Consulting’s comments on the proposed European Regulation on advanced therapy products issued by the…
This document summarizes VCLS’s comments on the Draft Regulation and on the Consultation Paper, published by the European Community on…
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Clinical Trials in Australia
Although the major drug development regions of the world are recognized to be North America, Europe and Japan, continuing growth…
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