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Summarising Clinical Efficacy Data for a New Drug Application

Level:
Advanced
Area:
Drug Development
Code:
DDA23
Duration:
03:30:00
Workshop profile:
This workshop is appropriate for regulatory/medical communicators who are moderately experienced in writing clinical regulatory documents.
Objective:
This workshop will focus on distinguishing between the Integrated Summary of Effectiveness (ISE) and the Summary of Clinical Efficacy (SCE) for common technical document (CTD) format submissions to the US Food and Drug Administration.
Content:
The teaching style will be primarily lecture with an exercise and some opportunity for discussion. The workshop leader will focus on what regulatory/medical communicators need to know to effectively write the high-level clinical efficacy documents required specifically by the US Food and Drug Administration for a new drug application (NDA) or biologics license application (BLA), namely the Integrated Summary of Effectiveness (ISE) vs the Summary of Clinical Efficacy (SCE). Associated regulations and guidelines will be discussed, as well as the source documents and other tools needed for generating these documents.