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

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.

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.

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