Non sponsored Workshop preceding this 16th OS
One year into ICH M10
Keeping our finger on the pulse
PDF renditions of the PowerPoint presentations can be viewed and downloaded from this page by clicking the specific point on the program. The program itself can be viewed and downloaded by clicking here.
Program details of the ICH M10 Workshop
| 08:45 | 09:00 | Welcome – dynamics of the meeting |
| Incl. Past current and future challenges for a global BMV Guideline – slides 01. Introduction | ||
| 09:00 | 10:00 | Session 1: Setting the Scene – General items (Plenary) |
| 09:00 – 09:15: Scope interpretation – matrix definition – pivotal studies (Philip Timmerman) – slides G01FB-0 | ||
| 09:15 – 09:25: updating historical validations (Lee Goodwin) – link to slides: see afternoon session | ||
| 09:25 – 09:35: Cross validation – working in the new paradigm (Tsvetelina Ivanova) – link to slides: see afternoon session | ||
| 09:35 – 09:40: Re-analysis of positive predose in BE study? (Tom Verhaeghe) – link to slides: see afternoon session | ||
| 09:40 – 09:50: ISR, incl. case study rom regulatory Feedback (Stuart McDougall) – slides G05FB | ||
| 09:50 – 10:00: Feedback on General items from a recent JBF meeting on ICH M10 – slides G06 JBF G | ||
| 10:30 | 12:20 | Session 2a: Setting the Scene – Chromatography (Parallel) |
| 10:30 – 11:00: FB from pre-meeting survey in support of the round tables – link to slides: see afternoon session | ||
| 11:00 – 11:30: FB from pre-meeting survey for CHROM Themes not selected for round table | ||
| – Tissues – how are you interpreting the requirements? (Steve White) – slides C07 | ||
| – Choosing the right regression model (Lee Goodwin) – slides C08 | ||
| – Matrix effect – special population, haemolysed and lipemic (Enric Bertran) – slides C09 | ||
| – Carry over assessment during samples analysis (Petia Milusheva) – slides C10 | ||
| – Focus on Metabolites (Philip Timmerman) – slides C11 | ||
| 11:30 – 11:40: Feedback on General items from a recent JBF meeting on ICH M10 – slides C12 JBF C | ||
| 11:40 – 11:50: Stuart Mc Dougall/Lee Goodwin – Surrogate/rare/preclinical matrix for CHROM | ||
| 11:50 – 12:20: Q&A on themes and additional questions from the survey | ||
| 10:30 | 12:00 | Session 2b: Setting the Scene – LBA (Parallel) |
| 10:30 – 10:40: Dilutional Linearity & Parallelism (Robert Nelson) – link to slides: see afternoon session | ||
| 10:40 – 10:50: Singlicate vs duplicate analysis (Richard Hughes) – link to slides: see afternoon session | ||
| 10:50 – 11:00: Surrogate/rare/preclinical matrix for LBA (Gregor Jordan) – link to slides: see afternoon session | ||
| 11:00 – 11:10: Chrom. requirements infecting LBA, incl. tissues/blood stability (Jo Goodman) | ||
| 11:10 – 11:20: Dilution QCs during sample analysis (Salvatore Calogero) – link to slides: see afternoon session | ||
| 11:20 – 11:30: Feedback on LBA from a recent JBF meeting on ICH M10 – slides L06 JBF L | ||
| 11:30 – 12:00: Q&A on themes and additional questions from the survey | ||
| 12:00 | 13:00 | Lunch Break |
| 13:00 | 16:40 | Round Table Discussions ICH M10 themes/chapters identified by the EBF and meeting delegates |
| 13:00 | 14:30 | Round tables General themes |
| 1. Scope interpretation – primary matrix definition – (M: Enric Bertran/Delphine Maux) – slides G01FB-A | ||
| 2. Scope interpretation – rare matrix vs. tissues – (M: Steve White/Salvatore) – slides G01FB-B | ||
| 3. Scope interpretation – Defining Pivotal studies definition – (M: Katja Zeiser/Michaela Golob) – slides G01FB-C | ||
| 4. Updating historical validations – when, how and why (not)? – (M: Lee Goodwin/Robert Nelson) – slides G02FB | ||
| 5. Is it allowed to re-analyse positive predose in BE study? – (M: Tom Verhaeghe/Gwenda Pynaert) – slides G03FB | ||
| 6. Cross validation – working in the new paradigm – (M: Tsvetelina Ivanova/Matthew Barfield) – slides G04FB | ||
| 14:50 | 16:40 | Round tables CHROM themes |
| 1. Fitting hybrid assays in ICH M10 – day-to-day practice – (M: Luca Ferrari/Kamil Sklodowski) – slides C01FB | ||
| 2. Whole blood stability – (M: Jörg Faber/Enric Bertran) – slides C02FB | ||
| 3. Analytes and matrices: focus on urine – (M: Delphine Maux/Steve White) – slides C03FB | ||
| 4. Dilution QCs during assay validation & sample analysis – (M: Petra Struwe/Rob Wheller) – slides C04FB | ||
| 5. Stock and working solutions stability – (M: Tom Verhaeghe/Rebecca Sleigh) – slides C05FB | ||
| 6. Surrogate/rare/preclinical matrix for CHROM – (M: Stuart McDougall/Lee Goodwin) – slides C06FB | ||
| 14:50 | 16:40 | Round tables LBA themes |
| 1. Dilutional Linearity & Parallelism – (M: Robert Nelson/Katja Zeiser) – slides L01 | ||
| 2. Singlicate vs duplicate analysis – (M: Richard Hughes/Gwenda Pynaert) – slides L02FB | ||
| 3. Surrogate/rare/preclinical matrix for LBA – (M: Gregor Jordan/Michaela Golob) – slides L03FB | ||
| 4. Chrom. requirements infecting LBA, incl. tissues/blood stability – (M: Jo Goodman/Kyra Cowan) | ||
| 5. Dilution QCs during sample analysis – (M: Salvatore Calogero/Anna Laurén) – slides L05FB | ||
| 17:30 | 18:15 | Session 3: FB General themes (Auditorium) |
| 18:20 | 19:00 | Session 4a: FB Chromatography themes (Auditorium) |
| 18:20 | 19:00 | Session 4b: FB LBA themes (Jupiter) |
| 19:00 | Adjourn | |
