Services for AMNOG (Arzneimittelmarktneuordnungsgesetz)
G-BA advice meeting
- Scenarios of expected G-BA feedback
- Preparation of briefing documentation
- Discussion of comparator
- „Translating“ the advice into the AMNOG dossier
Development of value story
- Discussionofmedicalneedandrisk-benefitratio
- Context story of endpoint and subgroup analyses
- Value story-central theme
Development/Medical Writing Modules 1-5
- Endpoint & subgroup definition
- Development of operationalisation tables & texts
- Incorporation of validated response criteria
- Modul 4: automated table creation
Written comment to IQWiG/G-BA evaluation preparation for oral hearing
- Benchmarking against previous oral hearings
- Evaluation of pro-and con arguments to G-BA‘s assessment
- Preparation master response document
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