Biomedicine is a constantly evolving and dynamic space where advancements are made rapidly. Regulatory bodies play a crucial role in this process, ensuring public safety and supporting the development of novel treatments and vaccines. Scientific advice, conducted by the Paul-Ehrlich-Institut (PEI) and by the Scientific Advice Working Party (SAWP) on behalf of the Committee for Medicinal Products for Human Use (CHMP) is an important tool to guide successful drug development, with the aim to support innovation and improve the basis for evaluation of safety and efficacy of new medicinal products.

Dr. Lukas Aguirre Dávila from the Paul-Ehrlich-Institut gave us an in-depth insight into the process and procedures involved in scientific advice at the PEI and the CHMP/SAWP. He outlined what scientific advice does and does not cover. This gave the audience a clear understanding of what to expect.

We would like to thank Dr. Aguirre Dávila very much for his excellent talk and look forward to welcoming him on a regular basis as part of the TRAIN Academy program. Until now, Dr. Jens Reinhardt had been the speaker for this module. We would also like to thank him for his many years of commitment to our Continuing education program.