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Paediatric Drug Development

How to meet the new regulatory requirements and benefit from the new commercial incentives by skillful development of products for use in children. This course is ideal for you if you need to be on top of the new EU paediatric drug development regulations that came into force in January 2007. It covers not only the regulations but also the medical and scientific background, enabling delegates to gain an all-round understanding of this critical area. By the end of the course you will be able to: - Understand the regulatory requirements introduced in the new regulations, together with the associated commercial incentives. - Assess which products are affected and when. - Appreciate the ethical issues involved. - Take a science-based approach to compiling a Paediatric Investigation Plan. - Evaluate formulations for use in children - Understand the complementary roles of PK, PD, safety and efficacy data - Plan the timing of paediatric development on the basis of ethical and scientific principles together with the concept of deferment.

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About Us

Since 1987, we have been delivering quality training to the pharmaceutical, healthcare, CRO and related industries. As well as delivering technical courses supporting clinical research functions, we also offer a wide range of personal development courses to ensure that skills learnt can be applied in the workplace.

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Rostrum Training Solutions Ltd

24 Lansdowne Road
Tilehurst
Reading
Berkshire
RG30 4QU

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