Driving Value from Regulatory Intelligence

Overview:

Regulatory intelligence focuses on understanding regulations as well as less obvious expectations in order to achieve regulatory success. This can be with new product submissions as well as legacy product lifecycle management. Knowledge gained from regulatory intelligence allows life sciences companies to get products to market faster, maintain regulatory compliance, and better serve patients.

Why you should Attend:

Regulatory is in the critical path to product launch, which means speed and quality of the submissions process is essential to getting products to market (and to patients) as quickly as possible. However, regulatory pathways and processes are complex and not fully detailed in published regulations.

Insights gained from a knowledge management approach to regulatory intelligence is essential to achieve right-first-time performance. The webinar will present multiple approaches to capturing insights to health authority expectations. These approaches include mining health authority correspondence, leveraging regulatory systems analytics, identifying experts inside and outside of the organization, and, where possible, frequent engagement with the authority.

Areas Covered in the Session:

• Understand health authority expectations beyond the requirements
• Be able to identify analytical capabilities within RIM systems
• Gain insights into reviewer’s and inspector’s biases and achieve better outcomes

Who Will Benefit:

• Regulatory Affairs Leaders 
• Operations Leaders