Kick-off Meeting through the Innovation Office at the BfArM
Kick-off Meetings organised by the Innovation Office at the BfArM provide a new discussion platform for early dialogue with applicants in addition to the already established Scientific Advice and Pre-submission Meetings. This service is especially open to academic research laboratories (universities, research organizations), start-ups or small enterprises with limited regulatory experiences.
The purpose of a Kick-off Meeting by the Innovation Office is to raise awareness and understanding of the general regulatory requirements or procedures and the available supportive tools of the BfArM at a very early stage of development. This early dialogue helps to reveal questions, challenges and difficulties and provides useful guidance for the further project planning and, if necessary, regulatory requirements by the authority. This applies to both the development of medicinal products (e.g. orphan drugs) and medical devices (e.g. medical apps with their intended purposes).
Kick-off Meetings are essentially characterized by the following:
- provide information on general regulatory issues
- are intended to be much earlier than the already established advice procedures at the BfArM and hence are not subject to a concrete list of questions related to an already planned development programme
- are addressed to institutions / companies with limited regulatory experience (e.g. academic research groups, start-ups);
- may be requested for innovative products.
According to the BfArM´s tasks and advisory opportunities, this particularly covers the early identification of data to be generated and of specific requirements with regard to pharmaceutical quality, preclinical and clinical data according to the relevant guidelines. In the case of medical devices, for example, the BfArM can already provide information on a possible classification as a medical device (for example in the case of medical apps) and the resulting regulatory consequences at an early stage.
Detailed advice on specific aspects (e.g. design of clinical trials, biostatistics) related to individual development projects is not in the scope of Kick-off Meetings. However, the need for subsequent “Scientific Advice” may be the result of a Kick-off Meeting; this advice needs to be applied for separately.
Detailed information about the scope and nature of a Kick-off Meeting through the Innovation Office are summarised in the "Guidance for Applicants“. This guidance document also contains details on how to apply for a Kick-off Meeting and how the meeting is prepared and conducted. In addition, this document provides detailed guidance for filling-out the application form.
In case of questions related to the procedure the following contact is provided:
Tel.: +49 (0)228 99 307-4053