The English version of the ICH GCP guideline has now been included in a new Profess publication. This concise (A5) compendium contains relevant guidelines for anyone conducting drug research:
- Declaration of Helsinki
- Guidance on the request to the competent authorities for authorization of a clinical trial
- Guidance on Investigational Medicinal Products
- EU Guideline for Good Manufacturing Practice Annex 13 for IMPs
- Guidance for the preparation of Good Clinical Practice Inspections.
Profess Medical Consultancy B.V has been certified by the accreditation committee of the Quality Register V&V (Nursing and Care-takers)
NEW SOP-M Quality System
A set of standard operating procedures to conduct investigator-initiated studies with medical devices in Europe in compliance with current regulatory requirements. The quality system is written in English languageNEW SOP-H Quality System
A set of standard operating procedures required to conduct investigator-initiated (non-commercial) studies in Europe in compliance with current regulatory requirements. The quality system is written in English languageDEMO SOP-H
SOP-Z Quality System
A set of standard operating procedures required to conduct investigator-initiated (non-commercial) studies in the Netherlands in compliance with current regulatory requirements. The quality system is written in Dutch languageDEMO SOP-Z
Prof. Dr. H. Pieterse, M.Sc, Ph.D.
