Regulatory support

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EMA’s Innovation Task Force

Provided by European Medicines Agency

EMA

The Innovation Task Force (ITF) is a multidisciplinary 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.

The objectives of the ITF are to:

* Establish a discussion platform for early dialogue with applicants, in particular micro, small and medium-sized enterprises (SMEs), academics and researchers, to proactively identify scientific, legal and regulatory issues of emerging therapies and technologies;
* Address the impact of emerging therapies and technologies on current scientific, legal and regulatory requirements with the Agency’s committees and their working parties;
* Identify the need for specialised expertise at an early stage;
* Provide advice on the eligibility to Agency procedures relating to research and development, in conjunction with the Committee for Medicinal Products for Human Use (CHMP), the Committee for Medicinal Products for Veterinary Use (CVMP), the European Commission and national competent authorities (NCAs) as appropriate.

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Innovation offices in national regulatory agencies

Provided by EU Innovation Offices Network

HMA INNOVATION NETWORK

National scientific advice for developers of medicinal products or medical devices and other technologies to optimize prospectively their development programme. • Two in one approach = get two NCA opinions within one application

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Comprehensive Inventory of available regulatory support

Provided by CSA STARS

CSA STARS

a Comprehensive Inventory (CI) has been developed to assist European academic drug developers in finding support on regulatory affairs. The inventory lists various support services provided by national competent authorities, public actors and private entities by:
* Expertise area (ATMP, Biologicals, biomarkers, chemicals, diagnostics, drug repurposing, drug-device combinations, e/m health, ethical aspects, IVD/ Blood products, legal matters, medical devices, paediatric studies, statistics, societal aspects)
* Support activity (assistance in clinical trial application, pre-grant advice, GCP, GLP, GMP, non clinical, pre-clinical, paediatrics, Phase I, PHase II-III, Phase IV, pre-grant advice, quality)

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Regulatory Service

Provided by EATRIS – EUROPEAN INFRASTRUCTURE FOR TRANSLATIONAL MEDICINE

EATRIS

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. Our range of services include:

– 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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