Ineke Jonker graduated in pharmacy at the University of Utrecht, the Netherlands followed by a PhD in pharmacokinetic-pharmacodynamic relationships at Leiden University.
She has over 25 years of experience in regulatory affairs including substantial experience in the regulatory aspects of global drug development, market approval and regulatory compliance of human medicinal products and medical devices. Ineke hold senior regulatory positions in Organon and Genzyme and worked as director of the Regulatory Affairs division at consultancy company Xendo with her group of 20 RA consultants.
Currently Ineke works as independent consultant in regulatory affairs and drug development at her own company Eagle Pharma Consult. She combines her work as a consultant with education a.o. at the MSc course of TOPRA and as Assistant Professor at Paul Janssen Futurelab.
- Regulatory Affairs
- Drug development
- Drug development and RA: advice gene and cell therapy product
- Drug development and RA: advice established product with new route of administration
- RA advice cell therapy
- Advice FDA pre-IND meeting: monoclonal antibody combination
- RA advice CRO oncology
- TOPRA MSc, module 1 Strategy
- Quality management, module leader
- Paul Janssen Futurelab, Assistant Professor, module Market approval
- In-house, client-specific training