Mechanism of Coordinated Access to OMPs

Published by IRDiRC

EUnetHTA HTA Bodies Mechanism of Coordinated Access to OMPs Orphan Medicine Regulatory Affairs Reimbursement Research and Drug Development

Early dialogue with payers /Medev – MoCA provides a mechanism for European countries to collaborate on coordinated access to orphan medicines in a voluntary, dialogue-based approach, intended to create a fluid set of interactions between key stakeholders, across all aspects of a product

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Marketing Authorization under Exceptional circumstances

Published by IRDiRC

Exceptional Circumstance Marketing Authorisation Regulatory Affairs

The MAUEC enables the marketing authorization of medicines for which the applicant would otherwise be unable to provide comprehensive data on the efficacy and Safety under normal conditions due to reasons of extreme rarity of the condition, technical impossibility to generate comprehensive knowledge, or ethical constraints.

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EMA Qualification of novel methodologies for medicine development

Published by IRDiRC

Committee for Orphan Medicinal Products Early Access Support Regulatory Affairs Scientific Advice

The EMA Qualification process is a voluntary, scientific pathway leading to either a CHMP (Committee for Medicinal Products for Human Use) Qualification opinion or a qualification advice on innovative methods or drug development tools

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Potential for Synergy with Paediatric Regulation (+2 years of Market exclusivity)

Published by IRDiRC

Early Access Support Paediatric Medicine Paediatric Regulation Potential for Synergy Regulatory Affairs

Potential for synergy between EU Orphan (Regulation (EC) No 141/2000) & Paediatric Regulation (Regulations (EC) No 1901/2006 and 1902/2006)

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EMA Marketing Authorization (MA) with conditions

Published by IRDiRC

Efficacy Data EMA Conditional Marketing Authorisation Marketing Authorisation Regulatory Affairs Safety Data

A marketing authorisation may be granted with certain conditions in order to ensure the collection of additional Safety and or efficacy data.

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Business Pipeline Meetings

Published by IRDiRC

Budgeting Business Pipeline Meeting Early Access Support Regulatory Affairs Scientific Advice Scientific Expertise

The business pipeline activity is a tool for accurate budgeting and identification of the most appropriate resources and scientific expertise.

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EMA Initiative for Patient Registries

Published by IRDiRC

Early Access Support Patient Data Patient Registry Regulatory Affairs Scientific Advice

Patient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time. Patient registries can play an important role in monitoring the Safety of medicines

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

Published by IRDiRC

Early Access Support Healthcare Professional Regulatory Affairs Research and Drug Development Scientific Advice Stakeholder Engagement

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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EMA small-medium enterprises (SME) office

Published by IRDiRC

Administrative Assistance Early Access Support Financial Asssitance Regulatory Affairs Regulatory Assistance SME SME Office

The EMA’s SME office promote innovation and the development of new medicines for human and veterinary by offering financial, administrative and regulatory assistance to micro, small and medium-sized pharmaceutical companies.

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Certification for advanced therapy medicinal products

Published by IRDiRC

Advanced Therapy ATMP Certification Certification Committee for Advanced Therapies Early Access Support Regulatory Affairs

The European Medicines Agency’s Committee for Advanced Therapies (CAT) provides a certification procedure for advanced therapy medicinal products (ATMPs) under development by micro-, small- and medium-sized enterprises (SMEs) only

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The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575. The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.

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