Let's Combinate - Drugs + Devices

Por: Subhi Saadeh
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!
224 episodios disponibles

Latest episodes of the podcast Let's Combinate - Drugs + Devices

Mostrando página 8 de 12

082 - CTD Structure for Combination Products, US vs. EU Submissions and Regulatory R&R with Niedre Heckman 26/04/2023
081 - ISO TC 84, ISO11608, Committee Work and Advancing the State of the Art with Bob Nesbitt 19/04/2023
080 - 9 CCI Tests in 10 Minutes, Probabilistic vs. Deterministic, and CCI vs. Permeation with Derek Duncan 12/04/2023
079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young 05/04/2023
078 - Prevention is Not New, Incentives in Health Care, and Integrated Combination Products with Ramin Rafiei 29/03/2023
077 - 8 Databases and How To Use Them with Michelle Lott 22/03/2023
076 - GMP Training, Competence, Human Error and Mentorship with Joanna Gallant 15/03/2023
075 - Shortages, Pricing, Mastering New Skills, and Building Deep Understanding with Ben Locwin 08/03/2023
074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman 01/03/2023
073 - Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal 22/02/2023
072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa 15/02/2023
071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols 08/02/2023
070 - The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul Jansen 01/02/2023
069 - EU MDR Extension with Michelle Lott 25/01/2023
068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge 18/01/2023
067 - mRNA, Flu Vaccines, Good Presentations, and Non-Linear Career Paths with Jane M. True 11/01/2023
066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio 04/01/2023
065 - "8 Quality Lessons from Losing 100 Lbs " with Subhi Saadeh 28/12/2022
064 - Pharma and Medical Device Development Processes, DFSS and Design Reviews with Skip Creveling 21/12/2022
063 - Combination Products Regulatory, Going Wide, and Patient Impact with Niedre Heckman 14/12/2022
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