Dear Investigator,
Within Europe and more specifically within Belgium, Direct To Patient (D2P) shipments have limitations within the current regulatory framework. In an ever changing environment, interest has been shown to further elaborate on the options of D2P shipments.
A working group has been established with participation of the Belgian Federal Agency for Medicines and Health Products (FAMHP), the Ministry of Social Affairs & Public Health, Patient organizations, Industry, Academic Organizations as well as Industry Associations to further explore those options and understand the regulatory implications.
In an effort to influence current regulations, this working group is reaching out to you, as Investigator of Clinical Trials, to share your current experience and future interest on D2P shipments by completing this questionnaire.
This questionnaire will help to define and scope the future needs of D2P shipments and create a regulatory environment supporting the needs of the Pharma Industry.
Notes:
• For the purpose of this questionnaire, D2P means shipment of IMP from a clinical site to a patient, from a pharmacy to a patient or shipments from a depot to a patient.
• It is possible that answering this questionnaire requires the input of different departments of your hospital. Please take the time to consolidate information with your colleagues.
• In any case, your feedback will be treated anonymously. If you wish to receive the survey's output, you can provide your email.
Kind regards,
The D2P Working Group
