Historically, the Regulatory submission and approval process in the life sciences industry has been very reliant on non-standardized documents. Within the last few years, however, regulators have increasingly focused on the submission of structured data and compliance with SPL, xEVMPD, IDMP and UDI standards. Although the move to a structured approach bring advantages, it also brings the challenge of ensuring that data and documentation remain in sync. Moving forward, industry professionals must determine whether to take a data- or document-driven approach.
Fortunately, the technology already exists to provide seamless synchronisation between documents and data. Leading organizations are taking advantage of structured authoring to adopt a simplified, standardized approach; one where it is possible to edit a single data-point that can be automatically pulled and synchronised across all relevant documents.
This webinar examines the practicalities, challenges and benefits of structured authoring, and provides some use case examples in the Regulatory space. This webinar will:
• Define structured authoring and how it relates to Life Sciences
• Illustrate ‘data-first’ versus ‘document-first’ approaches
• Identify the benefits of structured authoring in the Regulatory space
• Discuss Regulatory use cases for structured authoring