Support with clinical trial and clinical investigation authorisation

Would you like to quickly and correctly apply for an authorisation for your clinical trial or clinical investigation involving radioactive products?

>> Contact our experts for efficient guidance. <<

Is a licence required for clinical trials involving radioactive products in Belgium?

The use of radioactive products (in vivo or in vitro) in human or veterinary medicine, particularly in clinical trials or clinical investigations, is subject to a legal obligation. The Royal Decree of 12/07/2015 (Articles 7 and 33) stipulates that you must obtain prior authorisation from the FANC (Federal Agency for Nuclear Control) before you can start the research.

How do you obtain an authorisation to conduct a clinical trial or clinical investigation involving radioactive products?

This authorisation, which specifies the radioactive product and the conditions for its use, is only granted after approval by the FANC/AFCN on the basis of an application form. It is crucial that this file is compiled correctly and completely in order to avoid delays or rejection.

Our Expertise: Focus on medical radiation physics, dose assessment and radiation protection

Some of the specialised and critical parts of your application are in the section on medical exposure, point 4 of the application form (in Dutch, French or English). This is where the expertise of our certified experts in medical radiation physics and health physics comes in handy.

Vinçotte Controlatom supports you by providing the required expertise and documentation for the following key components:

• Dose estimation: Our recognised medical radiation physicists in the field of nuclear medicine calculate and document the expected effective dose and/or organ dose resulting from exposure throughout the entire clinical trial or clinical investigation.

• Advice on justification and optimisation: Our recognised medical radiation physicist and recognised health physics experts provide the legally required advice demonstrating how justification and optimisation are applied within your clinical trial or clinical investigation.

This advice includes a detailed substantiation with regard to, among other things, imaging, dose exposure and radiation protection, and contributes to the conformity of your clinical trial with the applicable regulations.

Vinçotte, your experienced partner in applying for a FANC licence for clinical trials or investigations

Vinçotte Controlatom has a strong track record in successfully supporting numerous authorisation applications for clinical trials involving radioactive products in Belgium.

We have experience with applications for both diagnostic radiopharmaceuticals and therapeutic radiopharmaceuticals.

Our support can go beyond the mandatory advice and dose estimations. If desired, we offer more extensive support, such as:

• Optimising study protocols with regard to radiation protection

• Support in drawing up implementation protocols and imaging guidelines, among other things.

Our expertise ensures that your application not only complies with legislation, but is also scientifically and practically optimised for fast and efficient approval.

Would you like to quickly and correctly apply for an authorisation for your clinical trial or clinical investigation involving radioactive products?

>> Contact our experts for efficient guidance. <<

Related Radiation Protection Services

As a specialist in radiation protection, Vinçotte Controlatom offers a comprehensive solution for nuclear medicine and clinical studies:

• Radionuclide Therapy Training: Vinçotte Academy provides training, available in Dutch and French, to train your staff in accordance with legislation.
• Physical Inspection/health physics: Vinçotte ensures the radiation protection of your staff, the public and your environment by carrying out physical inspection of sources of ionising radiation.
• Individual and environmental dosimetry: Vinçotte monitors the radiation dose of personnel and the environment through dosimetry, as an essential part of the safety and health of your employees.