This Trial Master File training will review the essential elements of a TMF for clinical trials. The activities of set-up, maintenance, and monitoring will be discussed using check-lists and case studies to highlight common deficiencies and potential solutions.
Why Should You Attend:
This webinar is very much essential for Professionals involved in a clinical trials, either as a clinical site or a sponsor/CRO as it will provide valuable suggestions about which documents are essential according to FDA requirements for drugs, biologics and medical devices. The instructor will discuss common deficiencies identified by FDA auditors during review of TMFs and provide potential solutions and best practices of implementation related to set up, maintenance and quality control of the TMF for drugs, biologics and medical devices.