Workshop on clinical development and scientific advice in ophthalmology

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TitleWorkshop on clinical development and scientific advice in ophthalmology
Date27/10/2011 - 28/10/2011
LocationEuropean Medicines Agency, London
SummaryThis 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.

All documents

Name Language First published Last updated
Agenda - European Union regulatory workshop in ophthalmology (English only) 2011-07-04  
European Union regulatory workshop in ophthalmology - Summary and report (English only) 2012-09-06  
European Union regulatory workshop in ophthalmology - Expression of interest form (English only) 2011-07-04  
Presentation - Day 1: Visual function endpoints in clinical trials clinical view (English only) 2011-11-15  
Presentation - Day 1: Visual function endpoints industry view (English only) 2011-11-15  
Presentation - Day 1: Visual function endpoints the regulatory perspective (English only) 2011-11-15  
Presentation - Day 1: Inherited retinal disease (English only) 2011-11-15  
Presentation - Day 1: Gene and molecular therapy; an industry view (English only) 2011-11-15  
Presentation - Day 1: Advanced therapy in retinal and macular degeneration (English only) 2011-11-15  
Presentation - Day 1: Advanced therapy in retinal disease regulatory view CAT (English only) 2011-11-15  
Presentation - Day 1: The orphan perspective (English only) 2011-11-15  
Presentation - Day 1: Macular edema (English only) 2011-11-15  
Presentation - Day 1: Industry view on DME and macular edema secondary to RVO (English only) 2011-11-15  
Presentation - Day 1: Regulation of products for macular oedema (English only) 2011-11-15  
Presentation - Day 1: ‘Dry’ Age-related macular degeneration (AMD) (English only) 2011-11-15  
Presentation - Day 1: Dry AMD – industry view (English only) 2011-11-15  
Presentation - Day 1: Dry AMD - the regulatory view (English only) 2011-11-15  
Presentation - Day 2: Uveiitiis - Clinician/Academic view (English only) 2011-11-15  
Presentation - Day 2: Intra-ocular inflammation: industry view (English only) 2011-11-15  
Presentation - Day 2: Intraocular Inflammation regulatory views (English only) 2011-11-15  
Presentation - Day 2: Prevention of corneal graft rejection: clinical view (English only) 2011-11-15  
Presentation - Day 2: Limbal stem cell therapy: industry view (English only) 2011-11-15  
Presentation - Day 2: Prevention of graft rejection (English only) 2011-11-15  
Presentation - Day 2: Limbal stem cell therapy (English only) 2011-11-15  
Presentation - Day 2: Dry eye disease: a tear film and ocular surface challenge (English only) 2011-11-15  
Presentation - Day 2: Meibomian gland dysfunction (English only) 2011-11-15  
Presentation - Day 2: Ocular surface biomarkers and inflammation (English only) 2011-11-15  
Presentation - Day 2: Dry eye (English only) 2011-11-15  
Presentation - Day 2: Dry eyes – regulatory perspectives (English only) 2011-11-15  
Presentation - PIP session: Overview of paediatric legislation for pharmaceuticals (English only) 2011-11-15  
Presentation - PIP session: Overview of childhood visual impairment and blindness (English only) 2011-11-15  
Presentation - PIP session: PDCO evaluation of ophthalmology paediatric investigation plans (English only) 2011-11-15  
Presentation - PIP session: Current clinical and research picture in paediatric anterior segment disorders (English only) 2011-11-15  
Presentation - PIP session: Overview of paediatric investigation plans for uveitis (English only) 2011-11-15  
Presentation - PIP session: Paediatric uveitis (English only) 2011-11-15  
Presentation - PIP session: Paediatric glaucoma overview of existing PIP decisions (English only) 2011-11-15  
Presentation - PIP session: Paediatric glaucoma (English only) 2011-11-15  
Presentation - PIP session: Retinopathy of prematurity (English only) 2011-11-15  

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eye2011@ema.europa.eu