A key step in the preparation of a paediatric investigation plan (PIP) for a new medicinal product is to define the PIP strategy, ie, to define how the studies/data extrapolation/waiver/deferral combination will cover, for each targeted indication, all subsets of...

An EMA workshop in London gave an important insight into the implementation of the European regulation on Advanced Therapy Medicinal Products (ATMPs).

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Every time there is a new regulation requested by the government, or generated by the industry needs, our scientific and technical contributions not only help us to remain updated but also aware of the philosophy underlying new regulations. Dr Emmanuelle Voisin, CEO...

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).

Emmanuelle...

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...

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.

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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...

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 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...

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.

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