DDF54 – Non-clinical study reports

Description

Participants of this workshop will receive an overview of the regulatory guidelines and individual parts of the NCSR and relevant source documents, as well as submission requirements. Thereby, the medical writer’s role in the preparation of the NCSRs will be highlighted.

Participant profile: The non-clinical study report (NCSR) is a comprehensive document that presents the findings and results of studies conducted on substances or products in preclinical or laboratory settings. Hence, those who stand to benefit from this workshop are regulatory personnel and scientific/medical writers in the pharmaceutical industry, those at CROs or medical writing agencies involved in regulatory documentation, or within academic groups/technology transfer departments at universities, etc.