Orphan Drug Designation (ODD)

Most health authorities promote the development of orphan drugs, by offering a series of incentives to companies developing treatments or diagnostics for rare diseases.

Clinical Trial Application (CTA)

The conduct of clinical trials is subject to prior authorization from health authorities, to ensure the protection of clinical trial subjects.

Marielle Fournier and Anne Dupraz-Poiseau describe US and EU rules governing prefilled syringes, pen injectors and innovative drug-delivery systems for biologics and consider the safety, quality and efficacy development challenges for manufacturers.

Anne...

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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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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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...

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