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

European Biotech sector struggles to survive funding crisis, Monthly, June 2009

2009
The Center Watch

One in five European small biopharmaceutical companies faces the rick of bankruptcy by the end of 2009. the situation could worsen if the economic downturn continues into 2010, warns the European Biopharmaceutical Enterprise (EBE).

Chapter RAPS: Working as an Independent Consultant in Regulatory Affairs

2009
RAPS Career Book

The European Regulations for Orphan Medicinal Products have been successfully implemented in the EU. Many companies have used or are using these regulations as is demonstrated by the high number of applications to the COMP. Only a limited number of products with Orphan Medicinal Product Designation have reached the market.

Update on the implementation of the European ATMP regulation

2009
TOPRA

A July 2009 adoption/publication of a revised Annex I of Directive 2001/83/EC is foreseen. Discussions on how to appropriately assess combined ATMPs are advanced, with the CAT medical device experts directly involved in these discussions.

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.

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