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Paediatric Drug Development

This half day masterclass under the expertise of Klaus Rose Consulting, will provide a focus on: paediatric clinical trials, legislation considerations, Paediatric Investigation Plan and the impact of paediatric legislations in both US and EU

Since the European Paediatric Regulation was introduced in 2007, companies developing new medicinal products or new indications/routes of administration/pharmaceutical forms are obliged to present age-appropriate formulations for the paediatric population within a Paediatric Investigation Plan (PIP) to the European Medicines Agency. Paediatric drug development has become an essential part of drug development in general, it is a very complex area encouraging coherent strategies and close collaborations and communications between industry and health authorities.Why You Should Attend:Whatever your position in drug development, you should have sufficient background knowledge. You might be directly involved in PIPs, you might be asked for advice, or you might work in a management, regulatory affairs, technical or clinical development position; without background understanding you might miss job opportunities or not have sufficient background for good decisions.

When

8 Jul 2014 @ 08:30 am

8 Jul 2014 @ 12:30 pm

Duration: 4 hours


Where

Holiday Inn

6 Coram Street

Greater London

United Kingdom


Organised by

SMi Group Ltd.

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