Course Description

A narrative is a short document that is required by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to briefly describe the events in the life of a patient. These narratives are required when a patient enrolled in a study, after taking the study medication or approved drugs (post-marketing), has discontinued the study because of an adverse event, had one or more serious adverse events, or died. FDA, EMA, and International Conference on Harmonization (ICH) guidance documents call for the submission of a study subject’s experience in narrative form for those who meet these specific criteria. This web seminar will provide a set of guidelines, instructions, and templates for the writing of clinical and post-marketing case narratives for reporting adverse events.

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Learning Objectives

• Describe relevant regulatory requirements in producing good quality case narratives
• Define and evaluate the critical data elements
• Examine special situations and challenges
• Describe and practice the skills necessary for generating well-written case narratives for reporting to regulatory authorities

Who Should Attend

• Drug Safety Professionals
• Pharmacovigilance Personnel
• Regulatory Affairs Professionals
• Clinical Development Personnel

Instructor

The course will be led by one of the following instructors:

Azita Ahmadi, B.S.

Click here for complete trainer biographies

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.