Alexander Jerman from Sferogen, a pre-clinical stage biotech company in Slovenia, sought regulatory advice regarding the development of their innovative virus-like particle vaccine candidate. With the support of ISIDORe, Sferogen engaged with regulatory experts from EATRIS ERIC in the Netherlands to gain insights into the necessary and beneficial steps to ensure compliance with regulatory standards.
The primary focus of the collaboration was to discuss general regulatory guidelines and address specific questions related to Sferogen’s vaccine development process. The discussions covered various topics, including the steps required for scientific advice from national regulatory authorities (NRA), the introduction to the innovation office at the Paul-Ehrlich-Institut (PEI), guidelines for live-attenuated influenza vaccines, and discussions on relevant animal models and Good Laboratory Practice (GLP) requirements.