173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's
🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letsco...
29 Jan 202532min
172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead
🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letsco...
22 Jan 202534min
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, ...
13 Jan 20257min
170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)
By viewing ISO 13485 through the lens of interconnected Plan-Do-Check-Act (PDCA) cycles, Subhi offers a fresh perspective that simplifies the implementation of this quality management standard. He exp...
8 Jan 20259min
169 - Should You Study Bioengineering in 2025? My Decade-Long Perspective
In this episode, Subhi Saadeh, a seasoned professional in the pharma and medical device industry, shares his insights on whether choosing bioengineering is the right career path. Drawing from his 10+ ...
1 Jan 202516min
168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth
In this episode of Let's Combinate, host Subhi Saadeh discusses the significance of audits as a key appraisal activity and draws parallels with personal self-assessment inspired by Peter Drucker's boo...
25 Dec 202413min
167 - Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst
In this episode of Let's Combinate, host Subhi Saadeh dives into the world of digital transformation in healthcare with Dr. Timothy Aungst, a visionary pharmacist and digital health expert. Dr. Aungst...
18 Dec 202441min
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 ecosyst...
11 Dec 202420min
