Sign up to save your podcasts
Or
Share 166 - Sync or Sink: 3 Levels of Harmonization for Combination Product Success
Share to email
Share to Facebook
Share to X
Share to email
Share to Facebook
Share to X
Or
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. 😅
View all episodes
By Subhi Saadeh
4.9
1313 ratings
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. 😅
More shows like Let's Combinate - Drugs + Devices
View all
Marketplace
8,622 Listeners
Fresh Air
37,766 Listeners
Planet Money
30,734 Listeners
Global Medical Device Podcast powered by Greenlight Guru
91 Listeners
The Daily
110,865 Listeners
Up First from NPR
56,021 Listeners
The Indicator from Planet Money
9,501 Listeners
SmartLess
57,297 Listeners
The Ezra Klein Show
15,371 Listeners