- Research with a medicinal product & extra review competent authority
- Definition of research with a medicinal product
- The competent authority: CCMO or Ministry of Health, Welfare and Sport
- Primary submission to the competent authority
- Timelines competent authority
- During and after the research & the competent authority
- Voluntary Harmonisation Procedure
- Types of research
- Research with a medicinal product
- Research with a medical device
- Vaccine research
- Research on cell therapy
- Research on gene therapy/medicinal product with GMO
- Research with subjects under the age of 16 years
- Research with incapacitated subjects
- Research with gametes and/or (leftover) embryos and the foetus
- Other types of research
Do I have to submit my research for review?
To whom should I contact
Which MREC should I contact?
Find answers to these questions.Help-me-on-my-way!