Let's Combinate - Drugs + Devices

Let's Combinate - Drugs + Devices

Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!

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Episoder(257)

047 - "Truthful Not Misleading" with Darshan Kulkarni

047 - "Truthful Not Misleading" with Darshan Kulkarni

On this episode I was joined by Darshan Kulkarni, Host of DarshanTalks, Attorney at the Kulkarni Law Firm and Adjunct Law Professor at Drexel University. - Free Speech and Promotional Compliance - Mis...

24 Aug 20221h

046 - "Inflation Reduction Act" with Sarfaraz Niazi

046 - "Inflation Reduction Act" with Sarfaraz Niazi

On this episode of the podcast, I was joined by Sarfaraz Niazi. Dr. Niazi and I disucss: - The Inflation Reduction Act - Out of Pocket Costs - Part B and Part D Drugs - Price Negotiation vs. Price...

17 Aug 202232min

045 - "Combination Products around the Globe" with Susan Neadle

045 - "Combination Products around the Globe" with Susan Neadle

On this episode, we were joined again by Susan Neadle! This episode was focused on the current state of Combination Products globally. Susan and I discuss: - CPC Summit and Updates from FDA - Essentia...

10 Aug 202235min

044 -“Market Access” with Kasem Akhras

044 -“Market Access” with Kasem Akhras

On this episode, I was joined by Dr. Kasem Akhras, Senior Director, Translational Access, Geneconomics & Outcomes Research - New Products  at Novartis. Dr. Akhras and I discuss: -His Book "Frontiers i...

3 Aug 20221h 13min

043 - “Half Knowledge Can Hurt” with Shadeed Salam

043 - “Half Knowledge Can Hurt” with Shadeed Salam

On this episode of the podcast, I was joined by Shadeed Salem, the Founder and President of Synergy Bioscience. Shadeed and I discuss: -War Stories in method validation and NCR/OOS's -What is it that...

27 Jul 20221h 14min

042 - “Reproducible within Limits”

042 - “Reproducible within Limits”

On this episode of the podcast, I walk through some of the takeaways I got from reading "Statistical Method from the Viewpoint of Quality Control" by Walter A. Shewhart. ------------------------------...

20 Jul 202220min

041 - “Health Citizenship” with Jane Sarasohn Kahn

041 - “Health Citizenship” with Jane Sarasohn Kahn

On this episode of the podcast, I was joined by Jane Sarasohn Kahn of Health Populi and THINK-Health. Jane and I discuss: - US Healthcare System - Healthcare economics before Healthcare economics - ...

13 Jul 20221h 9min

040 - “Good Science is Good Science” with Ben Locwin

040 - “Good Science is Good Science” with Ben Locwin

On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: - Behavioral Neuroscience and the soft skills of Quality - Quality, Compliance a...

6 Jul 202250min

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