DIA 2025 Global Annual Meeting

Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-25-509-L04-P; CME 6.50; RN 6.50

Pre-registration required and is an additional fee. *Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory. Already registered? Log in to DIA's My Account My Events. Patient experience data, through patient-reported outcomes (PROs) and other clinical outcome assessments (COAs) are an increasingly important component of regulatory drug submissions and health technology assessments (HTAs). Instructors will take participants on an in-depth evaluation of the key topics important in successful ePRO implementation, including:

• Selecting, adapting and developing patient-reported outcome measures to meet protocol objectives
• The case for ePRO – when to select an electronic approach, and when paper might suffice
• ePRO implementation best practices to ensure good measurement science
• Migration validity considerations and evidentiary requirements
• Language, translation and licensing considerations
• Implementation steps including vendor selection and user acceptance testing (UAT) best practices
• Modality choices – web vs app, and bring-your-own-device (BYOD) considerations
• Hot topics such as data change processes, mixing modes, special populations, etc.
• Q&A – discussion of participants' own hot topics.

Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Who should attend?

Professionals who have experience in clinical trials and patient engagement and wish to develop their skills on how PRO measurement is best implemented in clinical drug development programs.

Learning Objectives

• Demonstrate when to select electronic capture, when to use web vs app, and when to enable patients to use their own devices (BYOD)
• Apply industry best practices to ePRO implementation, translations and other processes such as PRO data changes
• Describe the implementation steps, possible bottlenecks and mitigations, and user acceptance testing best practices

Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-25-508-L04-P; CME 6.50; RN 6.50

Pre-registration required and is an additional fee. *Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory. Already registered? Log in to DIA's My Account/ My Events. According to the FDA (as well as other regulators), corrective and preventive action (CAPA) management and lack of proper investigation of challenges is a top observation among companies in the industry. In this short course, through interactive case studies, participants will learn how to conduct a proper investigation into a robust root cause analysis using industry standard tools in a toolkit approach. Additionally, participants will explore the challenges of proper CAPA planning and define appropriate effectiveness checks to ensure these observations do not occur again and how to properly document what was performed. Real-life case studies from various FDA 483s will be explored to showcase how to apply our toolkit approach to avoid action by regulators and ensure compliance in your processes and company culture. Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Who should attend?

Professionals who want a better understanding of how to perform a robust root cause analysis and CAPA plan to shift from a reactive organization to a proactive organization. This workshop is best suited for those in regulated industries in various industry areas such as quality, regulatory, operations/production, laboratories, etc.

Learning Objectives

• Determine the best approach to train individuals on industry best practices in CAPA management
• Utilize proven tools, in a toolkit format, to properly investigate observations and formulate robust CAPA plans and effectiveness checks to ensure compliance and remediation of observations
• Analyze case studies for techniques and strategies that will help solidify how to use the different tools