peter-van-amsterdam documents

Bioanalytical method validation - Global regulatory chalenges
Science Bioanalytical method validation - Global regulatory chalenges
Learning from issues in assay cross-validation / method transfers
Science Learning from issues in assay cross-validation / method transfers
EBF Survey: Quality Systems in Macromolecule Analysis
Science EBF Survey: Quality Systems in Macromolecule Analysis
Outsourcing: challenges and successes
Business Outsourcing: challenges and successes
Global Regulatory Issues: one BA method, one validation, one report
Science Global Regulatory Issues: one BA method, one validation, one report
Global Bioanalysis Consortium: Regulated Bioanalysis - A proposed Global Harmonization Process
Science Global Bioanalysis Consortium: Regulated Bioanalysis - A proposed Global Harmonization Process
Global Regulatory Issues: one BA method, one validation, one report
Documents Global Regulatory Issues: one BA method, one validation, one report
The EMA Bioanalytical Method Validation Guideline: process, history, discussions and evaluation of its content
Health & Medicine The EMA Bioanalytical Method Validation Guideline: process, history, discussions and evaluation of its content
GCP meets GLP- The sponsor perspective
Health & Medicine GCP meets GLP- The sponsor perspective
All for one, one for all - The Chinese BMV guidance in perspective to other guidelines
Science All for one, one for all - The Chinese BMV guidance in perspective to other guidelines