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

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.

European Biotech Outsourcing on Steep Learning Curve

2008
The Center Watch

Demand for contracted services in the European biotech sector is buoyant. As the industry matures and more biotech drug candidates reach clinical development, business opportunities for contract research organizations (CROs) and other service providers are growing.

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.

Pharmacokinetics

2006

As for chemicals, the development of numerous biopharmaceutical products has been accompanied during the last 15 years by a sustained and joint effort of the Regulatory Authorities and the Industry to set up contributory
regulatory guidelines.

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.

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