- You must be logged in to purchase this product.
DDA33 Estimands: A 360-degree approach for medical writers
€269.00 ex VAT
15 in stock
Description
The workshop is designed to facilitate interpretation of the International Council for Harmonisation (ICH) guideline E9(R1) 2019, which drives estimand development into trial design, and to clarify the MW’s role and responsibilities in relation to that of medical experts and statisticians in ensuring that estimands are considered as part of a proactive cross-functional approach to writing the CSP. At the end of the workshop, attendees should understand the concept of estimands and their impact on CSPs and other study-level documents, and have acquired the knowledge and skills to author or review CSPs that include estimands.
Participant profile: The workshop is for MWs working in the CRO or pharma environment, who have written at least one or reviewed several clinical study protocols (CSPs). Managers of MW groups will also benefit from understanding estimand-driven processes that impact business and wider operational considerations.