On 1/8, our regulatory support opens
From 1/8-26, ATMP Denmark offers regulatory support to public and private stakeholders working with ATMPs in Denmark.
What can you expect?
Development of advanced therapies requires early regulatory clarification. What requirements apply? Which authorities need to be involved? What needs to be in place before a clinical trial can begin?
ATMP Denmark offers non-binding regulatory guidance to public and private stakeholders working on the development or clinical trials of ATMPs in Denmark.
We are not a regulatory authority and cannot make decisions or assess data. That responsibility lies with the relevant authorities. In return, we can help you gain an overview of the process, identify regulatory issues, and find the right points of contact.
You can get help with:
Clarification of regulatory questions in your specific project (e.g. approval process, requirements, and expectations for documentation).
Which requirements for later commercialisation and clinical implementation should be considered already in the early phase.
Preparation for dialogue with regulatory authorities, including which questions are important to clarify early on, and what you may benefit from having ready.
We will do our best to answer your question.
Who can receive regulatory support?
We collaborate with both public and private stakeholders in Denmark—and provide guidance and support regarding ATMP.
Public hospitals
Academic environments
Private companies
How we help you move forward
Send an email to regulatorysupport@atmp.dk with a brief description of your project. We will confirm receipt and get back to you with suggestions for next steps, which may be a short clarifying meeting or a written summary.