Workshop on clinical development and scientific advice in ophthalmology

Event

On Monday, 12 January 2026, between 07:00 and 10:00 CET (Amsterdam time), this website will be unavailable due to scheduled maintenance.

Date: Thursday, 27 October 2011, All day
Location: 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)

First published: 04/07/2011 Last updated: 04/07/2011

European Union regulatory workshop in ophthalmology - Summary and report

Reference Number: EMA/450332/2012

English (EN) (431.97 KB - PDF)

First published: 06/09/2012 Last updated: 06/09/2012

European Union regulatory workshop in ophthalmology - Expression of interest form

English (EN) (269.84 KB - PDF)

First published: 04/07/2011 Last updated: 04/07/2011

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

English (EN) (4.17 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 1: Visual function endpoints industry view

English (EN) (889.72 KB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 1: Visual function endpoints the regulatory perspective

English (EN) (1.24 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 1: Inherited retinal disease

English (EN) (18.43 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

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

English (EN) (4.36 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

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

English (EN) (1.39 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

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

English (EN) (926.36 KB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 1: The orphan perspective

English (EN) (573.31 KB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 1: Macular edema

English (EN) (3 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

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

English (EN) (1.19 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 1: Regulation of products for macular oedema

English (EN) (574.25 KB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

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

English (EN) (1.36 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 1: Dry AMD – industry view

English (EN) (343.05 KB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 1: Dry AMD - the regulatory view

English (EN) (1.3 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 2: Uveiitiis - Clinician/Academic view

English (EN) (5.73 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

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

English (EN) (549.01 KB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 2: Intraocular Inflammation regulatory views

English (EN) (163.52 KB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

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

English (EN) (5.23 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

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

English (EN) (1.82 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 2: Prevention of graft rejection

English (EN) (15.72 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 2: Limbal stem cell therapy

English (EN) (454.08 KB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

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

English (EN) (9.04 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 2: Meibomian gland dysfunction

English (EN) (5.93 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 2: Ocular surface biomarkers and inflammation

English (EN) (2.27 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 2: Dry eye

English (EN) (572.02 KB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - Day 2: Dry eyes – regulatory perspectives

English (EN) (1.18 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - PIP session: Overview of paediatric legislation for pharmaceuticals

English (EN) (555.82 KB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

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

English (EN) (221.25 KB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

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

English (EN) (275.82 KB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

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

English (EN) (997.21 KB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

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

English (EN) (1.85 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - PIP session: Paediatric uveitis

English (EN) (35.95 KB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

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

English (EN) (29.01 KB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - PIP session: Paediatric glaucoma

English (EN) (3 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011

Presentation - PIP session: Retinopathy of prematurity

English (EN) (1.12 MB - PDF)

First published: 15/11/2011 Last updated: 15/11/2011