Workshop on clinical development and scientific advice in ophthalmology

Event

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Date: Joi, 27 octombrie 2011, Toată ziua
Locație: 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)

Prima publicare: 04/07/2011 Cea mai recent: 04/07/2011

European Union regulatory workshop in ophthalmology - Summary and report

Reference Number: EMA/450332/2012

English (EN) (431.97 KB - PDF)

Prima publicare: 06/09/2012 Cea mai recent: 06/09/2012

European Union regulatory workshop in ophthalmology - Expression of interest form

English (EN) (269.84 KB - PDF)

Prima publicare: 04/07/2011 Cea mai recent: 04/07/2011

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

English (EN) (4.17 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 1: Visual function endpoints industry view

English (EN) (889.72 KB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 1: Visual function endpoints the regulatory perspective

English (EN) (1.24 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 1: Inherited retinal disease

English (EN) (18.43 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

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

English (EN) (4.36 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

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

English (EN) (1.39 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

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

English (EN) (926.36 KB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 1: The orphan perspective

English (EN) (573.31 KB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 1: Macular edema

English (EN) (3 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

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

English (EN) (1.19 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 1: Regulation of products for macular oedema

English (EN) (574.25 KB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

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

English (EN) (1.36 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 1: Dry AMD – industry view

English (EN) (343.05 KB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 1: Dry AMD - the regulatory view

English (EN) (1.3 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 2: Uveiitiis - Clinician/Academic view

English (EN) (5.73 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

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

English (EN) (549.01 KB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 2: Intraocular Inflammation regulatory views

English (EN) (163.52 KB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

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

English (EN) (5.23 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

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

English (EN) (1.82 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 2: Prevention of graft rejection

English (EN) (15.72 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 2: Limbal stem cell therapy

English (EN) (454.08 KB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

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

English (EN) (9.04 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 2: Meibomian gland dysfunction

English (EN) (5.93 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 2: Ocular surface biomarkers and inflammation

English (EN) (2.27 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 2: Dry eye

English (EN) (572.02 KB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - Day 2: Dry eyes – regulatory perspectives

English (EN) (1.18 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - PIP session: Overview of paediatric legislation for pharmaceuticals

English (EN) (555.82 KB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

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

English (EN) (221.25 KB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

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

English (EN) (275.82 KB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

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

English (EN) (997.21 KB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

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

English (EN) (1.85 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - PIP session: Paediatric uveitis

English (EN) (35.95 KB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

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

English (EN) (29.01 KB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - PIP session: Paediatric glaucoma

English (EN) (3 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011

Presentation - PIP session: Retinopathy of prematurity

English (EN) (1.12 MB - PDF)

Prima publicare: 15/11/2011 Cea mai recent: 15/11/2011