Registration Rates:
Cancellation Fee: $
Frequently Asked Questions (FAQ) about Webinars
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Course Description:
Day 1: 12:00 PM - 1:00 PM
This webinar will provide an introduction to the European Paediatric Regulation including an overview of what goes into a paediatric investigation plan and the Regulatory approval process. Ideal for those wanting a basic overview of the Regulation and requirements.
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Who Should Attend:
Ideal for those wishing to familiarise themselves with the requirements of the European Paediatric Regulation and how it works in practice: research support and administrative staff members, clinical research associates, regulatory affairs professionals, product managers, statisticians, clinical data managers, marketing research staff will also gain knowledge from attending this webinar.
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Educational Objectives:
•Upon completion of this webinar, participants should be able to:
•Have a basic understanding of the Paediatric Regulation ¿ its aims and requirements
•Have a basic understanding of what goes into a Paediatric investigation plan (PIP) and where to source relevant guidance.
•Have a basic understanding of the PIP approval process by the PDCO and EMA
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Key Topics:
•The EU Paediatric Regulation
•The obligations for Pharmaceutical companies
•Outline of a Paediatric Investigation Plan (PIP) including waivers and deferrals
•Outline of the PIP approval process by the PDCO and EMA
•Where to find guidance when preparing and submitting PIPs
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Course Director(s):
Jill Challis
Senior Regulatory Manager
NDA Regulatory Science Limited
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Contact Course Manager:
Course Manager
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Frequently Asked Questions (FAQ) about Webinars
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