Mario Barilani
Regulatory Affairs Manager @Fondazione Telethon
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WORK HISTORY
Regulatory Affairs Manager @Fondazione Telethon
Milan, IT
Clinical trial applications (CTA)- EU. Responsible for- project management- regulatory support to other functions- CTIS management‣ Post-approval lifecycle management - EU. Responsible for- project management- procedure management (Type IB variations, Type II variations, PAM, renewal, PI linguistic review)- point of contact with publishing services‣ Regulatory intelligence‣ SOP writing
EDUCATION
Universidad de Granada
Post-graduate course, Advanced therapy medicinal products manufacturing from development to regulatory compliance
Università degli Studi di Padova
Doctor of Philosophy (Ph.D.), Biosciences and Biotechnology
Sapienza Università di Roma
Master of Science (M.Sc.), Genetics and Molecular Biology
Università di Pavia
Professional qualification, Biologo
Università degli Studi di Milano-Bicocca
Bachelor of Science (B.Sc.), Biotechnology
Communication of Scientific Research School
Private course
SKILLS
ABOUT MARIO BARILANI
The drive of my career is to pursue and support the development, translation and manufacture of advanced therapies (ATMP). My background core skills are in stem cell (hiPSC, hMSC) biomedical research for regenerative medicine and in nanomedicine approaches based on extracellular vesicles (exosome) and lipid nanoparticles to enable RNA therapeutics. Currently engaged in Global Regulatory Affairs, R&D funding and policy schemes in the area of cell and gene therapies for rare genetic diseases.Based in Milan, Italy.
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