Workshop on clinical development and scientific advice in ophthalmology

Event

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Date

Déardaoin, 27 Deireadh Fómhair 2011, All day

Áit

European Medicines Agency, Amsterdam, the Netherlands

This workshop is covering clinical development and scientific advice, and paediatric investigation plans relating to ophthalmology medicines. It is focusing on clinical development and methodological issues, including the choice of outcome measures and clinical-trial design. It is aimed at European regulators, clinical ophthalmologists and pharmaceutical-industry representatives working in all stages of clinical development in ophthalmology.

Documents

Agenda - European Union regulatory workshop in ophthalmology

Draft Reference Number: EMA/375555/2011

English (EN) (77.07 KB - PDF)

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European Union regulatory workshop in ophthalmology - Summary and report

Reference Number: EMA/450332/2012

English (EN) (431.97 KB - PDF)

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European Union regulatory workshop in ophthalmology - Expression of interest form

English (EN) (269.84 KB - PDF)

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Presentation - Day 1: Visual function endpoints in clinical trials clinical view

English (EN) (4.17 MB - PDF)

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Presentation - Day 1: Visual function endpoints industry view

English (EN) (889.72 KB - PDF)

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Presentation - Day 1: Visual function endpoints the regulatory perspective

English (EN) (1.24 MB - PDF)

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Presentation - Day 1: Inherited retinal disease

English (EN) (18.43 MB - PDF)

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Presentation - Day 1: Gene and molecular therapy; an industry view

English (EN) (4.36 MB - PDF)

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Presentation - Day 1: Advanced therapy in retinal and macular degeneration

English (EN) (1.39 MB - PDF)

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Presentation - Day 1: Advanced therapy in retinal disease regulatory view CAT

English (EN) (926.36 KB - PDF)

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Presentation - Day 1: The orphan perspective

English (EN) (573.31 KB - PDF)

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Presentation - Day 1: Macular edema

English (EN) (3 MB - PDF)

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Presentation - Day 1: Industry view on DME and macular edema secondary to RVO

English (EN) (1.19 MB - PDF)

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Presentation - Day 1: Regulation of products for macular oedema

English (EN) (574.25 KB - PDF)

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Presentation - Day 1: ‘Dry’ Age-related macular degeneration (AMD)

English (EN) (1.36 MB - PDF)

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Presentation - Day 1: Dry AMD – industry view

English (EN) (343.05 KB - PDF)

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Presentation - Day 1: Dry AMD - the regulatory view

English (EN) (1.3 MB - PDF)

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Presentation - Day 2: Uveiitiis - Clinician/Academic view

English (EN) (5.73 MB - PDF)

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Presentation - Day 2: Intra-ocular inflammation: industry view

English (EN) (549.01 KB - PDF)

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Presentation - Day 2: Intraocular Inflammation regulatory views

English (EN) (163.52 KB - PDF)

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Presentation - Day 2: Prevention of corneal graft rejection: clinical view

English (EN) (5.23 MB - PDF)

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Presentation - Day 2: Limbal stem cell therapy: industry view

English (EN) (1.82 MB - PDF)

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Presentation - Day 2: Prevention of graft rejection

English (EN) (15.72 MB - PDF)

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Presentation - Day 2: Limbal stem cell therapy

English (EN) (454.08 KB - PDF)

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Presentation - Day 2: Dry eye disease: a tear film and ocular surface challenge

English (EN) (9.04 MB - PDF)

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Presentation - Day 2: Meibomian gland dysfunction

English (EN) (5.93 MB - PDF)

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Presentation - Day 2: Ocular surface biomarkers and inflammation

English (EN) (2.27 MB - PDF)

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Presentation - Day 2: Dry eye

English (EN) (572.02 KB - PDF)

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Presentation - Day 2: Dry eyes – regulatory perspectives

English (EN) (1.18 MB - PDF)

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Presentation - PIP session: Overview of paediatric legislation for pharmaceuticals

English (EN) (555.82 KB - PDF)

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Presentation - PIP session: Overview of childhood visual impairment and blindness

English (EN) (221.25 KB - PDF)

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Presentation - PIP session: PDCO evaluation of ophthalmology paediatric investigation plans

English (EN) (275.82 KB - PDF)

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Presentation - PIP session: Current clinical and research picture in paediatric anterior segment disorders

English (EN) (997.21 KB - PDF)

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Presentation - PIP session: Overview of paediatric investigation plans for uveitis

English (EN) (1.85 MB - PDF)

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Presentation - PIP session: Paediatric uveitis

English (EN) (35.95 KB - PDF)

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Presentation - PIP session: Paediatric glaucoma overview of existing PIP decisions

English (EN) (29.01 KB - PDF)

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Presentation - PIP session: Paediatric glaucoma

English (EN) (3 MB - PDF)

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Presentation - PIP session: Retinopathy of prematurity

English (EN) (1.12 MB - PDF)

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