Regulatory professionals increasingly collaborate across diverse functional areas, especially those responsible for implementing or using technological solutions. To successfully foster relationships, avoid roadblocks, and establish shared expectations among teams within this context requires not only strong communication skills but also an acceptance of the dynamic nature of technological innovation and a fundamental understanding of associated workflows.

This webcast will provide an overview of common project management methodologies with a focus on the benefits of Agile methods, which, although used primarily in technological development, are beneficial across many other applications. Attendees will gain insight into associated principles, terminology, and tools and how the Agile framework influences the way development teams approach projects. In addition, participants will learn how to evaluate which methodology — traditional, Agile, or hybrid — best supports a given project and how to align cross-functional teams on ways of working to bring structure and clarity to projects.

The webinar will conclude with a live demo of AgileWriter.ai™, Synterex’s AI-enabled document authoring and management platform that leverages advanced machine learning techniques to produce high-quality clinical trial documents efficiently, saving up to 50 percent of time and cost on first-draft turnaround. AgileWriter also evolves with each use, incorporating feedback to continuously improve its performance. AgileWriter complements Agile project management methods by streamlining the clinical documentation development process, enabling teams to work iteratively and expeditiously.

Free

Learning Objectives

• Understand the key principles of the different project management methodologies used in the development of technology, including Agile.

• Analyze how to identify and influence project management styles of teams working on regulatory projects, including teams focused on the development, implementation, and use of technological solutions.

• Discover how to champion acceptance of change in line with the digital transformation occurring in the regulated space among sponsors and regulators.

Who Should Attend?

Industry professionals, including those with a focus on regulatory, clinical operations, information technology, or medical writing

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.