CHMP Protocol Assistance_ Scientific Advice Briefing ...
Rev. 1
CHMP
Briefing Document Template
[Standard headings in the template should be used whenever possible; if it is considered necessary to deviate from the pre-specified headings to accommodate product-specific requirements, alternative or additional headings/sections may be considered.
This annotated template should be read in conjunction with the relevant guidelines that can be found on the website of the European Medicines Agency: ‘EMA Guidance for Companies requesting Scientific Advice or Protocol Assistance’ (EMEA-H-4260-01-Rev.6).
Bracketing convention: {text}: Information that is required to be filled in; : Text to be selected or deleted as appropriate.
[Text] is for explanation and guidance.
Formatting convention: Verdana 9 pt, single space, justified.
References convention:
- For citation of literature references, footnotes are preferred, alternatively the format (first author , publication year) is recommended.]
Invented Name: {}
Active substance: {}
Pharmaco-therapeutic group: {}
Intended indication(s): {}
Applicant: {}
Version {}
Date: {DD/MM/YYYY}
Table of Contents
List of Figures 3
List of Tables 3
List of Abbreviations 3
I. Summary 4
II. Questions and Applicant’s positions 6
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