publication
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,…
publication
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.
publication
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…
publication
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…
publication
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…
publication
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…
presentation
Regulatory And Development Strategies For Gene & Cell Therapies
The launch of a product is one of the most critical moments in its life-cycle. The product trajectory is firm…
presentation
Successful Commercialisation of ATMPs Starts at the Bench
Despite their significant therapeutic potential, ATMPs face specific market access challenges compared to other therapeutic categories. These include high manufacturing…
