#380: Navigating the Complex World of Combination Products with Subhi Saadeh

Global Medical Device Podcast · 30 Aug 2024 · 38m · Episode 380

What this episode covers

Subhi Saadeh, host of the Combinate Podcast and expert in combination products, discusses the regulatory complexities of integrating drugs, devices, and biologics, including the differences between US FDA and EU regulatory pathways. He explains the definitions of single entity, co-packaged, and cross-labeled products, and addresses common misconceptions about the differences between drug and device quality systems. Saadeh also shares his journey of starting the podcast to maintain consistent learning and production, highlighting the importance of lifelong learning and leveraging coaching to balance technical and business aspects of the MedTech industry.

Most relevant to

early-stage companies

Topics

Mentioned

Companies: FDA, EMA, Pfizer, BSI, AAMI, ASTM, Rook Quality Systems
Products: Combinate Podcast

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The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.

#380: Navigating the Complex World of Combination Products with Subhi Saadeh

What this episode covers

Most relevant to

Topics

Mentioned

Related episodes from other shows

152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh

192 - What Is a Drug/Device Combination Product? (Non-Technical, Under 5 Minutes)

257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products

139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh

091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle