CVs
Summary of Education and experience:
M.Sc. Pharm.
ISO 9001 Lead Auditor. QMI (Quality Management Institute)
EMEA EudraVigilance User Training Course.
CQA Lead Auditor for a minimum of 10 years. The auditor has conducted audits
in most Europeans countries and USA. Established quality systems for Quality
Assurance and for the conduct of clinical trials.
Clinical Research Associate for 9 years, with responsibility for monitoring,
clinical trial protocol and report writing. In addition I was responsible
for establishing clinical quality systems for the conduct of clinical trials
to ensure compliance with ICH GCP and regula-tory requirements, and providing
training in GCP and monitoring.
Regulatory Affairs Officer for 3 years with main responsibility for the clinical
part of the dossier