Scientific Advice

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JoInternationalEMA-FDA Scientific Advice

Published by IRDiRC

Early Access SupportJoInternationalEMA-FDA Scientific AdviceRegulatory SciencesScientific Advice

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services have a program to provide parallel scientific advice (PSA) to sponsors. The goal of the PSA program is to provide a mechanism for EMA assessors and FDA reviewers to concurrently exchange with sponsors their views on scientific issues during the development phase of new medicinal products (i.e., new human drugs and Biologics).

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National Member State Scientific Advice

Published by IRDiRC

Early Access SupportNational Member State Scientific AdviceNational Scientific AdviceRegulatory AffairsScientific Advice

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 Innovation Task Force

Published by IRDiRC

Early Access SupportEarly Stage AdviceEMA Innovation Task ForceRegulatory AffairsScientific Advice

The ITF is a multidisciplinary EMA group that includes scientific, regulatory and legal competences. It was set up to ensure coordination across the Agency and to provide a forum for early dialogue with applicants on innovative aspects in medicines development. Area of interest: innovative therapeutics and techniques, innovative development methods, borderline products.
From the first request by the applicant, the procedure lasts approximately 8-10 weeks (ITF Secretariats confirms eligibility criteria approx. within 2 weeks; when confirmed, then approx. 2 weeks about experts’ involvement + meeting date after 4-6 weeks).

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