Global Labeling Conference

Regulatory Affairs leaders play the central role in shaping regulatory strategy. However, the demanding submission and approval process often consumes significant time as we seek market intelligence insights to guide the process. We’re navigating multiple websites, combing through massive documentation, and putting together manual comparisons, leaving little time for strategic reflection. Embracing AI-enabled solutions can streamline these repetitive tasks, allowing us to allocate more time to strategy.

Hayley Parker, Vice President, Global Regulatory Affairs for PepGen, will tackle this important topic. She will illustrate how advanced technology can facilitate the rapid generation of side-by-side label comparisons and expedite searches within and across SBAs and EPARs. She’ll highlight how applying Generative AI chat to SBA and EPARs content can accelerate insight generation, and how machine learning models help identify key data points in competitive clinical trials. And she’ll advise how to integrate these insights to accelerate strategy, submission, and approval.

Featured Topics:

• What’s in the Label and how to rapidly and effectively leverage that intelligence
• What’s not in the Label and how to find those insights to inform a faster pathway to approval
• Putting it all together: accelerated impact with AI-enabled technology