166 - Sync or Sink: 3 Levels of Harmonization for Combination Product Success

Subhi proposes a broader definition of harmonization, not just aligning regulations but also fostering synergy among drug and device teams. Subhi emphasizes the importance of creating seamless ecosystems for operational harmony, addressing both internal and external collaborations. Additionally, Subhi explores the complexities of regulatory differences between regions, advocate for standardized quality agreements, and stress the significance of relationship management between sponsors and contract organizations (CXOs). The ultimate goal is to achieve regulatory and operational harmony within the combination products space. 00:00 Introduction and Personal Insights 00:28 Defining Harmonization 02:38 Challenges in Regulatory Harmonization 03:43 Operational Harmony and Internal Collaboration 10:38 Sponsor and CXO Harmonization 14:15 Internal Drug and Device Harmonization 17:37 Solutions and Final Thoughts 20:41 Conclusion and Thank You ---------------------------------------- This talk was given at the PharmaED Resources Pre-filled Syringes & Injection Devices 2024 Conference: Exploring the Future of Parenteral Combination Products December 4-5, 2024, La Jolla, CA Note: Apologies for the audio not being of the quality you're used to —this is after hours of post-production. Trust me, the original was worse. 😅