Global Combination Products and Human Factors
Anoop Padival and Edward Halpern, combination product experts from AbbVie, are taking a deep dive into human factors considerations in the combination product field at Q1’s Combination Product Regulation Conference at the end of February. Padival and Halpern provide a preview into topics covered in their presentation.
Can you please give a brief description of your job title and what that entails?
Anoop Padival: I am a Manager in Strategic Global Labeling, Regulatory Affairs and I lead global labeling strategy for our Neuroscience Therapeutic Area (Drug and Combination Products). I am also the Chair of global labeling teams and lead global labeling cross-functional teams to develop labeling content.
Edward Halpern: I am a Human Factors Research Engineer for Combination Product Development and I lead human factors strategy and execution for combination products. I am also a global labeling team member for combination products.
Can you give a quick summary of your presentation?
AP/EH: We will cover how the development of labeling content for combination products is complex, involves extensive collaboration between cross-functional teams and extensive usability testing with the target population. We will also cover how the effective management of the complex process and parallel work streams is critical for developing the desired content and its globalization.
What are the 3 main takeaways you hope attendees learn from your presentation?
AP/EH: We hope attendees learn that human factors evaluation is a critical component in defining and driving population-specific content of Instructions for Use (IFUs). Additionally, we hope they learn IFUs developed using optimal human factors strategy delivers the intended content to target audience. Another lesson we hope attendees learn is that the globalization of content should include input from global and affiliate cross-functional teams.