Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-506-L04-P; CME 2.75; IACET 2.75; RN 2.75
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How can we better train regulatory writers to acquire the skills needed to successfully do their jobs? The importance of standardized training programs for regulatory writers will be discussed, along with experiences developing training programs.
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DIA 2021 Learning ObjectivesDescribe the importance of organizations having standardized training programs for regulatory medical writers; Explain and apply the available industry-level guidance that can help with developing training programs for regulatory writers; Compare the approaches used by a sponsor and by a CRO to develop training programs for new medical writers.