Specialization

Research Quality and Preclinical Project Management

Focus of research

Main activities (50/50)


• Tytgat Institute Research Quality management
The Tytgat Institute(TI) has an ISO15189 international accreditation for its research activities (Dutch Board of Accreditation, #M304) and is compliant with GcLP. For this I:
* design, implement and manage the TI quality system (QS)for research and preclinical studies
* am internal auditor and external auditor host
* perform Process analyses & Risk management
* validate processes, and coordinate equipment and assay validation
* perform Management Review of quality and general policy
* coordinate all aspects of TI Standard Operating Procedures (SOPs)
* train and inform TI staff on TI QS, auditing and risk management
* am SMART advisor for general management (Annual Plan, Action Plan, QPI’s)
* am Quality manual author

• (Pre)clinical Project Management:
The Tytgat Institute performs research and services for fee for external partners (pharma & CRO). For this I
* Manage all aspects of Tytgat Institute "external" preclinical studies (Set-up, Deliverables, Budget, Staff planning, Sample logistics, Data storage, Contracts and Invoicing)
* am Tytgat institute’s intermediair/contact for CRO and pharmaceutical companies

Contact:

i.c.gaemers@amsterdamumc.nl

www.tytgatresearchservices.com

Tel: +31205668832