member of
Activities
Consulting projects
2019 - current
- CMC/Biopharm/RA early NCE
- CMC/Biopharm/PK Phase II NBE
- DMPK NDA
- Biopharm-/PK-/CMC NCE Phase I/II
- Business Integration
QP activities
2019 - current
- QP for manufacturers of biologicals
- QP for import / production of clinical trial samples and comparators
- QP for solid oral dosage forms
Audits
2019 - current
- GMP audit IMP-API NCE manufacturer, India
- GMP audit IMP CMO, UK
- GMP audit API / FF biotech manufacturer, USA
- GMP audit QC contract laboratory, Japan
- GMP mock audit, preparation for inspection by authorities, Germany
Training
2019 - current
- GxP training courses at Saarland University, KIT - Karlsruhe and FSU Jena
- QM training at the University of Potsdam
- Business Development and R&D Training, University of Leipzig
- CMC Training, BB Summer School, Berlin
- Online training Role of RA in R&D, production and marketing of drugs and medical devices