Medical Writing Medical Writing in Paediatrics Writing applications for Paediatric Investigation Plans and waivers
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Volume 21, Issue 2 - Medical Writing in Paediatrics

Writing applications for Paediatric Investigation Plans and waivers

Abstract

Under EU legislation, a Paediatric Investigation Plan (PIP) and/or a waiver must be agreed in advance with the European Medicines Agency (EMA), for all new medicinal products seeking marketing authorization; the same applies for already authorized products under certain circumstances. In principle, the application needs to be submitted early in the development (before completing basic Phase I studies in adults), which may require an innovative and creative approach to the drafting of the necessary documents. The aim of this article is to provide a guide on already existing and available help and advice, to provide further suggestions and comment, and to illustrate common mistakes; the reader should then be able to increase the chances of a more rapid procedure with a higher probability of a positive outcome of the procedure.

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Articles

Medical writing in paediatrics: Children and the future
Message from the President
Challenges of paediatric drug development and impact of paediatric legislation
Writing applications for Paediatric Investigation Plans and waivers
Preparing the Paediatric Investigation Plan application
ADHD: A true neurodevelopmental disorder?
Medicines information for patients: Insights into research and practice for medical writers
The MHRA perspective on the new pharmacovigilance legislation
Are stem cells the future of healthcare?
O, safety, quo vadis?
Crowdpower in the era of ‘health 2.0’
Networking effectively: Essential for being successful in business
The moving image and your business
Forgive me for repeating myself: Self-plagiarism in the medical literature
In the Bookstores
Journal Watch
The Webscout
Manuscript Writing
Regulatory Writing
English Grammar and Style
Out On Our Own

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  • Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
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  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

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