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M.I.T. Consulting Ltd.

 

Veijo Ikonen

Career & Task Overview

  • Senior Development manager
    • Setting up quality systems; SOPs, protocol review committee
    • Re-engineering of clinical development process
    • Training of clinical development personnel from basic to excellence level
    • Support and advising of clinical trial and regulatory operations
    • Medical writing, set-up and management of Quality operations in response process of marketing application of new chemical entity
  • Quality Assurance Auditor, GCP/GLP
    • In-house & on-site audits internationally
    • Audits of clinical sites, central laboratories & CROs
    • Study specific audits, audits of systems, and for-cause audits
    • Preparation for and participation in inspections by FDA and European authorities
    • Quality of study protocols, reports and regulatory documentation of new chemical entities
  • Head of a business unit

For more than 20 years experience in Pharmaceutical Industry