Peter van Amsterdam

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I started my career working as a senior lab technician in metabolism research and bioanalysis. Followed by several positions in General Analytical Chemistry and Physical Chemistry departments, while in parallel graduating in Analytical Chemistry at the University of Amsterdam in 1988, I moved back to bioanalytical arena in 1989. In addition to the position of group leader in the local bioanalysis department I took on the functions of project leader and study director for various projects in the pre-clinical stage. Over the years I got more and more involved in contracting out and managing external bioanalytical activities at CROs in Europe and North America. In 2002 I moved with a team t...

bmv bioanalysis ema anvisa fda cro guidance guideline mhlw gcp glp regulatory compliance method validation china bioanalytical method validation cfda quality gclp outsourcing bioanalytical cross-validation matrix composition gbc clia cap immunogenicity macromolecules lba regulatory comliance cultural awareness contracting out europe bionanalysis nihs

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Peter van Amsterdam

Präsentationen

Bioanalytical method validation - Global regulatory chalenges

The EMA Bioanalytical Method Validation Guideline: process, history, discussions and evaluation of its content

Outsourcing: challenges and successes

Global Regulatory Issues: one BA method, one validation, one report ...

EBF Survey: Quality Systems in Macromolecule Analysis

Global Regulatory Issues: one BA method, one validation, one report ...

Global Bioanalysis Consortium: Regulated Bioanalysis - A proposed Global Harmonization Process

Learning from issues in assay cross-validation / method transfers

GCP meets GLP- The sponsor perspective

All for one, one for all - The Chinese BMV guidance in perspective to other guidelines