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Session 2: End-to-end Labeling Part 1: The Development Phase
Session Chair(s)
Hayley Parker, PhD, MSc
Vice President Regulatory Affairs
PepGen, United States
Lauren Brunke, PharmD, RPh
Senior Director, Global Regulatory Affairs, Global Labeling
Eli Lilly and Company, United States
To support end-to-end successful delivery of a product, when should you start developing your ‘label’ and how broad should the term ‘label’ be? Target Product Labels (TPL) have typically focused on the prescriber, but as the world of labeling becomes more complex, this session focuses on how the TPL could include packaging, instructions for use (IFUs), supporting software, risk minimization, patient materials, and the supply chain, to enhance supply of the product globally. This session will focus on some case-studies, examples, and considerations where factoring in these broader elements of labeling into the TPL process has been utilized to successfully optimize the supply of the product to the end user.
Learning Objective : At the conclusion of this session, participants should be able to:- Evaluate opportunities to broaden the scope of the TPL to assist supply of the final product
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Identify additional stakeholders which may be required to support broader TPL development
- Discuss best practices and learnings when implementing a broader TPL process
Speaker(s)
Speaker
Hayley Parker, PhD, MSc
PepGen, United States
Vice President Regulatory Affairs
Speaker
Shaun Wallisa
Eli Lilly and Company, United States
Associate Director Global Regulatory Affairs, Global Labeling