Personalized Medicine: From Concept to Reality, Nov edition

2008
Fierce Biotech

As major pharma companies position themselves to market drugs in years to come, they’re seeing fewer blockbuster therapies on the horizon. The future lies in following the development model used by biotech companies to advance new medicines designed to target smaller populations with much more effective therapies.

The Implementation of the European Tissues and Cells Directives in France, July 2008

2008
Informa Uk Ltd

The main purpose of the tissues and cells directives has been to define a minimum level of quality and standards to support the expanding field of transplantations of human tissue and cells in the European Economic Area. The implementation of the EU tissues and cells directives and how France handled the process has been explored.

Regulatory Innovative Biomedical products on nanotechnology requires a combination of drug and device evaluation expertise

2006
The Regulatory Affairs Journal

Regulating innovative biomedical products based on nanotechnology requires a combination of drug and device evaluation expertise. Economic forecasts predict the market growth of nanotechnologies will reach hundreds of billion euros in the coming decade.

An insight into the Hearing on Advanced Therapies at the European Parliament

2006
EPP Group

The European Commission issued a proposed regulation in November 2005 on Advanced Therapy Products aiming to provide the much awaited harmonized regulatory framework for cell based products. This Regulation includes somatic cell therapies, gene therapies and also tissue engineered products (TEPs) in its scope and would close the regulatory gap as regards TEPs.

Harmonization Beyond the Implementation of the Clinical Trial Directive

2006
Thomson

In 1991 the European Commission (EC) initially proposed a clinical trial regulation rather than a directive. Although a regulation typically results in greater harmonization, unfortunately some member states preferred that the EC issue a directive that could be incorporated rather than override existing national clinical trial legislation.

Impact of the new pharmaceutical legislation on the development and registration of biological medicinal products in the EU ,TOPRA Vol 3, No.2

2006
Regulatory Rapporteur

This article reviews the impact of the new pharmaceutical legislation on the development of biotech products. The authors describe in details current and new challenges that will have an impact on the development and preparation of the registration dossier of biologicals.

Human Tissues: Consultants call for end to EU regualtory confusion

2005
Clinica

Manufacturers of human tissue engineered products (hTEPs) need to develop a very strong position paper to put an end to regulators treating so many of these products as cell therapy products and compelling manufacturers to comply with the medicinal products Directive, 2003/63/EC.

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

2005
Clinica

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

2005
Clinica

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

2005
Informa UK Ltd

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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