IRDiRC

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Development of product specific bio-analytical assays 

Published by IRDiRC

Bio-Analytical AssayBioassayDrug DiscoveryResearch and Drug Development

Measurement of drug concentrations in biological matrices (such as serum, plasma, blood, urine, and saliva) is an important aspect of drug development. These methods provide data to support the Safety and effectiveness of drugs, which may be needed to support applications for new drugs in regulatory pathways

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Stakeholders interactions – Patients Affairs Staff

Published by IRDiRC

Clinical DevelopmentEarly Access SupportFDA Regulatory AdvicePatient AdvicePatient Affairs StaffPatient EngagementPatient SupportRegulatory AffairsResearch and Drug Development

At the FDA, the Patient Affairs Staff (PAS) is devoted to supporting cross-cutting patient engagement activities across the FDA. Its mission is to coordinate and support patient engagement activities across FDA to facilitate awareness and collaboration with patients, their advocates and the FDA

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Decentralized trials 

Published by IRDiRC

Adaptative PathwayClinical DevelopmentClinical Trial DesignDecentralised TrialDigital EndpointPatient DataRegulatory SciencesResearch and Drug Development

Decentralized trials aim to improve patient access to trials by enabling patient follow-up from home or community care, increase the participation of more diverse populations, and enhancing data collection by combining the adoption of digital endpoints and telemedicine as applied to trials, decentralized trials aim

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European Patients’ Academy (EUPATI) toolbox

Published by IRDiRC

EUPATIOrphan DrugPatient InformationPatient TrainingResearch and Drug DevelopmentToolboxToolkit for Patient

The EUPATI Academy is the only in-depth training program for patient experts so far in EU that lasts 14months.
It includes an on online training program supported with two weeks of F2F training. The Academy is still operated by EPF, providing high quality training in drug development to patient from EMEA.

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EURORDIS’ Community Advisory Boards

Published by IRDiRC

Community Advisory BoardEurordisMedical ResearchOrphan Drug DevelopmentPatient AdvocatePatient InformationPatient OrganisationRare DiseaseResearch and Drug Development

Patient Community Advisory Boards are groups established and operated by patient advocates. They facilitate discussions in a safe harbour setting and under strict rules, an MOU and CA on the latest developments and challenges related to medical research and procedures in a disease area with the company or body conducting the research. The CAB can cover from preclinical to post marketing topics. The CAB depending on the areas of discussion can invite scientific expert to serve as advisors.

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