29.11.2022 Online Course on “Validation of Bioanalytical Methods” with Jaume Pascual Avellana, Director of Quality Assurance, and Carles Celma Lezcano Celma, Scientific Director at Kymos. The course is organised by the Universitat de Barcelona and Institut de Formació Contínua IL3 – Universitat de Barcelona (UB) and adresses professionals in the pharmaceutical and related sectors.
The objective of the course is to offer a global vision of the aspects regulated by the new ICHM10 regulation (still in the consultation phase) in comparison with the criteria already defined in the bioanalytical method validation guides of the EMA (European Medicines Agency) and of the FDA (Food and Drug Administration of the USA), currently in force, highlighting the differences, the consensus, the new proposals and including both the recommendations for the chromatographic methods (essentially by LC-MS/MS) and the immunological methods (ligand binding assays).
PROGRAM
9.30-10.00: Introduction
- Background
- Chronology
- General principles
10.00-11.00: Chromatographic methods
- Pre-study validation. Validation Parameters
- Sample analysis
11.00-11.30: Break
11.30-12.30: Ligand binding assays
- Pre-study validation. Validation Parameters
- Sample analysis
12:30-1:00 p.m.: Additional considerations and documentation
1:00-1:30 p.m.: Questions and discussion
Find link to participate here
