Challenges and ongoing initiatives towards better integrated EU scientific advice.

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Tác giả: Michael Berntgen, Pierre Demolis, Paolo Foggi, Iordanis Gravanis, Spiros Vamvakas

Ngôn ngữ: eng

Ký hiệu phân loại: 920.71 Men

Thông tin xuất bản: Switzerland : Frontiers in medicine , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 51837

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Scientific advice is the main avenue for clarification of EU regulators' scientific evidence requirements during medicines development. There are multiple avenues for seeking scientific advice in the EU with partially overlapping scope which creates room for divergence and contradictions
simplification and better integration among them could help harmonize EU regulators' requirements. Interaction with other decision makers providing advice along the lifecycle of medicines and other healthcare solutions reduces development uncertainties. The proposal for a new EU pharmaceutical legislation solidifies existing advice mechanisms and creates new avenues for enhanced integration of development support.

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