00. ITF Briefing Meeting Request Form

?Request for Early Interaction on Innovative DevelopmentsInteraction on innovative developments, organised under the remit of the Innovation Task Force (ITF), provide a forum for an early dialogue. Their scope covers regulatory, technical and scientific issues arising from innovative medicines development, new technologies and borderline products.Their objective is to facilitate informal exchange of information and guidance in the development process, complementing and reinforcing existing formal procedures.The scientific informal brainstorming discussions are led by experts from the Agency network, working parties and committees, where the best available scientific expertise is represented.The meetings are free of charge and 1,5 hr long.To apply for a briefing meeting, please complete this form and provide it (as a Word document) via HYPERLINK "" EudraLink (please create an EMA account (Self-Register) and follow the instructions provided).Please email us if you have further questions: HYPERLINK "mailto:itfsecretariat@ema.europa.eu" itfsecretariat@ema.europa.eu (human medicines) HYPERLINK "mailto:ITFvet@ema.europa.eu" ITFvet@ema.europa.eu (veterinary medicines)We will review your request and contact you with the outcome and next steps.Please type your responses in the fields provided.Applicant’s details Date of application:Click or tap here to enter text.Human or veterinaryHuman?Veterinary?Applicant/Organisation name:Click or tap here to enter text.Address:Click or tap here to enter text.Contact person name:Click or tap here to enter text.Contact e-mail:Click or tap here to enter text.Contact telephone:Click or tap here to enter text.Type of applicantType an 'X' in the appropriate box.SME?Large Enterprise?Academia?EU funded Consortium?Other?Other/ SME-number- please specifyClick or tap here to enter text.Product / Technology / Development method Tick the appropriate boxMedicinal single productMedicinal multiple products??Other products (e.g. devices,cosmetics, food)?Method/Methodology(e.g. Statistics, manufacturing, software, biomarker, validation)?Technology(e.g. nanotechnology,e-health)? Other?Other- please specify, if ATMP consideredClick or tap here to enter text.Stage of the developmentConcept / Proof of Concept?Preclinical?First administration to humans/ FiH?Clinical phase1 ? 2 ? 3 ?Post approval?Other- please specifyClick or tap here to enter text.Product / Technology / Development method (specify below)Name / identifierClick or tap here to enter text.Product/technology description(max. 100 words)Click or tap here to enter text.Mode of action(max. 100 words)Click or tap here to enter text.Intended use(max. 100 words)Click or tap here to enter text.UPI/RPI number- if previously assignedClick or tap here to enter text.ATC codeif knownClick or tap here to enter text.Therapeutic areas: please tick all relevant (at least one)Tick all that applyTherapeutic area ?Blood and lymphatic system disorders?Cardiac disorders?Congenital, familial and genetic disorders?Ear and labyrinth disorders?Endocrine disorders?Eye disorders?Gastrointestinal disorders?General disorders and administration site conditions?Hepatobiliary disorders?Immune system disorders?Infections and infestations?Injury, poisoning and procedural complications?Investigations?Metabolism and nutrition disorders?Musculoskeletal and connective tissue disorders?Neoplasms benign, malignant and unspecified (incl. cysts and polyps)?Nervous system disorders?Pregnancy, puerperium and perinatal conditions?Product issues?Psychiatric disorders?Renal and urinary disorders?Reproductive system and breast disorders?Respiratory, thoracic and mediastinal disorders?Skin and subcutaneous tissue disorders?Social circumstances?Surgical and medical procedures?Vascular disordersEnabling technologies/ innovation: please tick all relevant (at least one)Type of innovation Type an 'X' in the appropriate yellow box(es)Therapeutic innovation?Scientific innovation?Technical innovation?Tick all that applyEnabling technology(Parent Term)?Other innovation aspect / enabling technologyClick or tap here to enter text.?NanotechnologiesDirectly product-related?Synthetic biologyDirectly product-related?Genetically modified organism(s)Directly product-related?Novel biomarkers, omicsDevelopment-related: clinical?Medicines for tropical diseasesDevelopment-related: clinical?Biodefense/biowarfareDevelopment-related: clinical?BiomaterialsAssociated medical devices?MatrixesAssociated medical devices?Other associated medical deviceAssociated medical devices?PrintingAdvanced manufacturing?Bedside/point of care manufacturingAdvanced manufacturing?Mobile/portable manufacturingAdvanced manufacturing?Distributed manufacturingAdvanced manufacturing?Transgenic technologiesAdvanced manufacturing?3D printingAdvanced manufacturing?Novel/uncommon excipientOther ingredients?AdjuvantOther ingredients?Pharmacological chaperoneOther ingredients?BioenhancerOther ingredients?Photodynamic productSmart materials in active substance(s)?Other smart/advanced materialSmart materials in active substance(s)?Targeted release to specific site(s)Delivery methods?Controlled-release technologiesDelivery methods?New/uncommon pharm. form or route of admin.Delivery methods?Genome editing - deletionGenome editing?Genome editing - replacementGenome editing?Genome editing - regulationGenome editing?Human cell based in vitro modelsHuman cell-based?Human stem cell in vitro modelsHuman cell-based?OrganoidsNon-clinical development: other?Avatar, nude and humanised miceNon-clinical development: other?Physiologically-based pharmacokineticsNon-clinical development: other?Other in silico modelsNon-clinical development: other?Extrapolation proposedMethodology of clinical trials?Platform/Umbrella/basket trialsMethodology of clinical trials?Novel endpointsMethodology of clinical trials?Bayesian designsMethodology of clinical trials?Adaptive designsMethodology of clinical trials?Monitoring devices/sensors/systemsDigital healthcare?Closed loop systemsDigital healthcare?E/m-healthDigital healthcare?Big data analysisNovel data sources?Real world data analysisNovel data sourcesTo help us establish how innovative your product / technology / development method is, please specify the following:Same or similar substance/technology reviewed, approved or marketed in: (specify below)Click or tap here to enter ics to be discussed (please describe below) Scientific:Click or tap here to enter text.Regulatory:Click or tap here to enter text.General:Click or tap here to enter text.Previous/parallel contact with other EMA departments regarding this product / technology / development method (e.g. SA, Qualification, SME etc.) specify below:Click or tap here to enter text.Previous/parallel contact with other regulators regarding this product / technology / development method (e.g. National Competent Authorities, FDA, etc.) specify below:Click or tap here to enter text.Other Agency procedure(s) consideredType an 'X' in the appropriate yellow box(es). Click on links for further information HYPERLINK "" SME status? HYPERLINK "" ATMP Certification SMEs? HYPERLINK "" Scientific recommendation on advanced therapy (ATMP) classification? HYPERLINK "" Orphan medicinal product designation? HYPERLINK "" Paediatric applications? HYPERLINK "" Scientific advice / Protocol assistance? HYPERLINK "" Qualification of novel methodologies? HYPERLINK "" MUMS classification ?Any additional information you would like to give usClick or tap here to enter text. ................
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