The course is designed for professionals working on vaccine development who are in need of an introduction to the regulatory issues associated with the field. Day 1 will focus on prophylactic vaccines, including lectures and case studies on how to navigate the regulatory maze and how to plan a regulatory strategy, preclinical and Phase I-II of vaccine development, how to prepare a dossier for Medicine Agencies, CMC development. Day 2 will focus on cancer vaccines, with an introduction to the scientific part to understand the regulatory part better.”

Day 1 – Classic/prophylactic vaccines for infectious diseases
Welcome
How to navigate the regulatory maze and how to plan a regulatory strategy
CMC vaccine development
Preclinical vaccine development: Animal testing
Early phase clinical trials and clinical trials application
How to bring products to patients: Prepare a dossier
Exercise
Dinner

Day 2 – Cancer and therapeutic vaccines
Scientific basis for cancer vaccines
Cancer vaccines vs classical vaccines vs ATMPs
Vaccine development when dealing with a pandemic
Exercise

Faculty
Giovanni Migliaccio, Scientific Director of the Centro Valutazioni Biologiche e Farmacologiche (IT) and Senior Advisor for EATRIS
Leo van der Pol, Principal Scientist at Intravacc (NL)
Christopher Mann, Scientific & Regulatory Affairs Director at Asphalion (ES)
Lucia Gabriele, Head of Tumor Immunology Section, Department of Oncology and Molecular Medicine (ISS, Rome), and Co‐Chair of Vaccine, Inflammation and Immunomonitoring Platform of EATRIS