224 - ICH Q2 Explained: What Analytical Validation Really Requires
In this episode of Let’s Combinate, host Subhi Saadeh breaks down the ICH Q2 guideline with a practical focus on analytical procedure validation. The discussion covers key definitions, core validation...
28 Tammi 10min
223 - What’s Changing in ICH Q1 and What Isn’t: Understanding Stability Expectations
In this episode of Let’s Combinate: Drugs and Devices, host Subhi Saadeh breaks down the 2025 draft update to the ICH Q1 guideline and explains what has actually changed and what has stayed the same.I...
21 Tammi 9min
222 - How ICH Guidelines Are Organized: Understanding the Q, S, E, and M Series
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh continues the Combinating with ICH series by breaking down how the International Council for Harmonisation (ICH) guidelines are o...
14 Tammi 12min
221 - What Is ICH and Why It Matters
In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh kicks off a new series focused on the International Council for Harmonisation (ICH) and its impact on drug and drug–device combination...
7 Tammi 14min
220 - Managing Oneself, Reflections and a New Series on ICH
🚀 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.letsc...
31 Joulu 20258min
219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh is joined by Ben Locwin to break down what’s changing in FDA pre-approval and pre-license inspections—and why the “inspection sid...
24 Joulu 202525min
218 - ICH Q13: Continuous Manufacturing EXPLAINED (Batch vs. Continuous)
In this short episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh breaks down ICH Q13 and what “continuous manufacturing” actually means. He compares batch vs. continuous, explains how a batch s...
17 Joulu 20259min
217 - 5 Fixable Problems Holding Back Drug–Device Programs
In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh addresses five significant quality issues in the combination product space. This episode provides practical insights and strategi...
10 Joulu 202517min
