228 - ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently
Continuing the ICH Q series with ICH Q5. This episode explains why Q5 exists, how to read it, and what it means for combination products. Q5 addresses quality challenges unique to biologics made in li...
4 Mars 6min
227 - When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics
Subhi Saadeh sits down with Georg Digel, founder of Elevate CAPA, to break down what should trigger CAPA, and how to investigate the right way using practical tools and better problem statements.Times...
24 Feb 28min
226 - Navigating China NMPA Medical Device Requirements | Standards, GMP Updates, Agents & Classification
In this episode, Subhi Saadeh sits down with Elaine (Yi Ling Tan), Creator and Principal Consultant at MedTech Chopsticks, to break down China medical device market access and regulatory compliance un...
18 Feb 29min
226 - ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions
In this episode of the ICH Q series, Subhi Saadeh covers ICH Q4, which focuses on pharmacopeial harmonization. He explains why ICH Q4 exists, the problem it was created to solve, and how the ICH Q4 fr...
11 Feb 8min
225 - ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in 10 Minutes
In this episode of Let’s ComBinate: Drugs + Devices, host Subhi Saadeh breaks down ICH Q3, the family of guidelines that define how impurities are identified, evaluated, and controlled in drug substan...
4 Feb 9min
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 Jan 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 Jan 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 Jan 12min
