Dear Sponsor,

In Europe and more specifically Belgium, Direct To Patient (D2P) shipments are limited within the current regulatory framework. Considering the growing enthusiasm of pharma companies, investigators and patients for D2P shipments in the USA, we want to investigate if the European market should not consider adapting its regulations in order to respond to this new demand.

A working group has been established with the participation of the Belgian Federal Agency for Medicines and Health Products (FAMHP), the Ministry of Social Affairs & Public Health, Patient organizations, the Industry, Academic Organizations and finally Industry Associations to further explore these options and understand the regulatory implications.

This working group is reaching out to you as stakeholder in Clinical Trials, so that you may share your experiences and show your future interest on D2P by completing this questionnaire.

The survey will help us define and scope the needs of D2P shipments in EU and help us support a change in the current regulations so that we can better meet the evolving needs of patients participating in clinical trials.

Thank you for taking the time to answer this questionnaire by 31st January 2018.



For the purpose of this questionnaire, D2P means shipments of IMP from a clinical site to a patient, from a pharmacy to a patient or shipments from a depot to a patient.

For the purpose of this questionnaire, Company refers to the whole organization (on a global scale). Some questions refer to previous experience with D2P that may exist within your organization at an international level.

It is possible that answering this questionnaire may require the input of several different business units of your organization. We would appreciate it if you could consolidate the information of your colleagues and provide a company-wide response to the questionnaire.

Your feedback will be treated anonymously.

If you wish to receive the survey’s output, you can of course provide your email.

Kind regards,

The D2P Working Group