Early access support

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EMA Scientific guidelines

Published by

Clinical DevelopmentClinical Trial DesignGuidelineRegulatory AdviceRegulatory Affairs

The European Medicines Agency’s Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for human medicines. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.

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European Paediatric Translational Research Infrastructure (EPTRI)

Published by EPTRI

Drug DevelopmentpaediatricRegulatory Affairsresearch infrastructureTranslational Research

The EPTRI Centralised Services are provided by the EPTRI CMO and dedicated experts. These services include:
*Providing access to paediatric patients’ cohorts
*Providing access to paediatric samples and related data
*Advice on in-vivo / in-silico non-clinical study design
*Advice on in-vivo / in-silico clinical study design
*Advice and document preparation for regulatory and ethics procedures
*Advice on preparing HTA reports for paediatric medicines, diagnostics, and medical devices
*Advice on data and sample sharing preparation
*Support with applications to public and private funding opportunities

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Qualification of novel methodologies for drug development: guidance to applicants (EMA/CHMP/SAWP/72894/2008). 2013

Published by EMA

Drug DevelopmentEMA Qualification

The EMA Qualification process is a new, voluntary, scientific pathway leading to either a CHMP Qualification opinion or a qualification advice on innovative methods or drug development tools

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EATRIS Regulatory support

Published by n/a

EATRISOrphan Drug DesignationRegulatory SupportScientic advice

Through a combination of in-house and external partnerships with a range of regulatory experts and groups, EATRIS can provide regulatory support for most types of product including: Expert opinion, Orphan Drug Designation and Scientific Advice application at the EMA, Pre-clinical and clinical plan development, Informal scientific advice with selected national competent authorities, for highly complex projects,
access to EATRIS Regulatory Database (free of charge) that contains information about the regulatory requirements, guidelines and legislations from 27 EU countries (as well as Norway, Switzerland, Turkey and Israel) regarding drug and medical device development derived from the application of European legislation.

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Rare diseases, orphan drugs, and their regulation in Asia: Current status and future perspectives

Published by IACMHR Co., Ltd.

Orphan DrugRegulatory Science

This paper describes the current status of the regulation of rare diseases and orphan drugs in Asia and we comparatively analyze the regulation of rare diseases and orphan drugs worldwide in order to examine the challenges to and future perspectives on promoting research on rare diseases and development of orphan drugs in China and other Asian countries.

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Single Patient Expanded Access

Published by IRDiRC

Early Access SupportOrphan DrugOrphan MedicineRegulatory AffairsResearch and Drug DevelopmentSingle Patient Expanded Accesss

This FDA program allows early access to drugs and medical devices before marketing approval, under regulatory oversight with collection of Safety data, to individual patients with serious or immediately life-threatening diseases or conditions who lack therapeutic alternatives. This includes emergency and non-emergency expanded access.

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