For products falling under the mandatory scope of the centralised procedure, integrating a Paediatric Investigation Plan (PIP) into a company's development programme can become very challenging.

 

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For some patients, compassionate use programmes (CUPs) are the only way to access promising medicinal products that are not yet authorized and for which clinical trials are either not available or in which these patients cannot participate.

 

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Over the last few years, the European authorities have undertaken substantial new regulatory initiatives regarding the conduct of drug development activities, Clinical Trial Application (CTA) and Marketing Authorisation Application (MAA) submissions.

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Representing more than a third of the world’s population, the Asia-Pacific is an attractive option for cost-effective clinical research regardless of whether the target market for the product is within or outside the region. However, if the clinical research is not...

An Independent Consultant is broadly defined as a person who is self-employed and works for clients in a specific field on a per-project basis. In this article, we provide a description of the general roles of a Regulatory Affairs Independent Consultant.

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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...

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