Regulatory Documentation for Pediatric Clinical Trials

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Join AMWA Northern California colleagues remotely for an informative presentation on the documents required in pediatric clinical trials.

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Please join AMWA Northern California colleagues for an online presentation from Nancy Katz, PhD, MWC , Principal Medical Writing Consultant at Illyria Consulting Group, Inc., discussing the special tasks and challenges in the development of critical documentation for pediatric clinical trials.

Nancy is an established member of the national and international medical writing community through professional work; and through her long and active association with AMWA at the national and chapter level; and with the Drug Information Asociation. She spoke about this topic recently at the DIA Annual Meeting in San Diego.

Nancy will describe the requirements of three critical documents associated with pediatric clinical trials: Paediatric Investigation Plans (PIPs); Pediatric Study Plans (PSPs); and pediatric protocols and amendments.

Nancy will be speaking live in a phone conference with registrants. A slide deck summarizing the presentation will be delivered to registrants for local display along with the phone conference connection details.

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