Let's Combinate - Drugs + Devices13 Jan 2025

171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?

In this episode of 'Let's Combinate,' host Subhi Saadeh delves into the challenges and complexities of working with prefilled syringes in regulatory, quality, and product development settings. Subhi, who has worked on vaccines, biologics, and small molecules in prefilled syringe systems He explores what makes a prefilled syringe a combination product and explains the varying regulatory requirements across different regions, including the US, EU, China, and Japan. The episode emphasizes the importance of understanding these differences to ensure success in product development and market approval. Saadeh also invites viewers to engage and provide feedback in the comments section.00:00 Introduction to Prefilled Syringes01:54 Understanding Combination Products02:32 Regulatory Frameworks for Prefilled Syringes04:59 Global Regulatory Perspectives06:10 Key Takeaways and ConclusionSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

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Episoder(247)

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239 - ICH Q11 in 6 Minutes

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238 - 6 Audit Strategies Every Auditor Should Know

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237 - ICH Q10: The Pharmaceutical Quality System

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236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

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235 - ICH Q8: How Pharmaceutical Development Actually Works

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22 Apr 10min

234 - ICH Q7: The GMP Framework for API Manufacturing

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15 Apr 13min