Case Narrative Writing for Reporting Adverse Events

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. 

• 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

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

Azita Ahmadi, B.S.

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$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-17-020-L01-P. Released: 3/17. 

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