DZIF Office for Scientific and Regulatory Advice (DZIF-OSRA)
The German Centre for Infection Research (DZIF) has been founded in 2011 and started in October 2011 with a new infrastructural measure and projects. The overarching aim of the DZIF is to make translation of basic research findings into new approaches and applications for the diagnosis, prevention and treatment of infectious diseases faster and more effective.
The DZIF Office for Scientific and Regulatory Advice (DZIF-OSRA) is part of an infrastructure called DZIF Product Development Unit (DZIF-PDU). DZIF-PDU has been implemented to ensure a tight connection of technology identification, clear and transparent exploitation plans and support for the translational research and development. DZIF-PDU consists of two offices:
- DZIF Translational Project Management Office (DZIF-TPMO) gives advice in commercial product development, elaborate corresponding plans and support the product development process. DZIF-TPMO is located at the Helmholtz Centre for Infection Research in Braunschweig
- DZIF Office for Scientific and Regulatory Advice (DZIF-OSRA) provides support on scientific and regulatory aspects in the translation of product candidates and is located at the Paul-Ehrlich-Institut in Langen.
How does DZIF-OSRA support translation?
We specifically offer:
- informal meetings (kick-off meetings) between DZIF research teams/investigators, PDU and PEI,
- ad-hoc availability through email and phone calls,
- regulatory research to define the critical path,
- point-of-contact into national, European level and international expert working groups,
- access to database of FAQ raised in the interactions of PIs with regulatory bodies,
- regulatory education and training (e.g. workshops).