Workshop on clinical development and scientific advice in ophthalmology

• Date:
  csütörtök, 27 október 2011, Egész nap
• Helyszín:
  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

European Union regulatory workshop in ophthalmology - Summary and report

Reference Number: EMA/450332/2012

European Union regulatory workshop in ophthalmology - Expression of interest form

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

Presentation - Day 1: Visual function endpoints industry view

Presentation - Day 1: Visual function endpoints the regulatory perspective

Presentation - Day 1: Inherited retinal disease

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

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

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

Presentation - Day 1: The orphan perspective

Presentation - Day 1: Macular edema

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

Presentation - Day 1: Regulation of products for macular oedema

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

Presentation - Day 1: Dry AMD – industry view

Presentation - Day 1: Dry AMD - the regulatory view

Presentation - Day 2: Uveiitiis - Clinician/Academic view

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

Presentation - Day 2: Intraocular Inflammation regulatory views

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

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

Presentation - Day 2: Prevention of graft rejection

Presentation - Day 2: Limbal stem cell therapy

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

Presentation - Day 2: Meibomian gland dysfunction

Presentation - Day 2: Ocular surface biomarkers and inflammation

Presentation - Day 2: Dry eye

Presentation - Day 2: Dry eyes – regulatory perspectives

Presentation - PIP session: Overview of paediatric legislation for pharmaceuticals

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

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

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

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

Presentation - PIP session: Paediatric uveitis

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

Presentation - PIP session: Paediatric glaucoma

Presentation - PIP session: Retinopathy of prematurity