Procedures set up by many (but not all) National Member State to offer scientific advice to developers of new medicines. The procedures can be similar but often less formal than for CHMP scientific advice/protocol assistance at the EMA; they may include written advice and/or face-to-face meetings. The procedures are not limited only to orphan product development and may vary between Member States.

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EMA Framework for stakeholder’s engagement – patients, academia, healthcare professionals

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsEarly Access SupportScientific AdviceStakeholder EngagementHealthcare Professional

The Agency has been interacting with its stakeholders since its inception. These stakeholder relations have evolved over time and the type and degree of interaction is varied depending on the stakeholder groups and fields of Agency activity.

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The European Network of Paediatric Research at the European Medicines Agency (Enpr- EMA) is a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children. Enpr-EMA enables networking and collaboration with members from within and outside the European Union (EU), including academia and the pharmaceutical industry

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