May 3-4, 2023
Visit Premier Research at OCT Europe. This conference will provide delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials.
Meet our speaker: Federica Martini, Ph. D., Associate Director, Regulatory Affairs, Premier Consulting
Federica Martini is a regulatory professional with 10+ years of experience in the pharmaceutical and biotech industries. She has a strong background in developing EU regulatory strategies, leading cross-functional teams in health authority interactions, and in supporting regulatory applications, including document development to support applications such as Scientific Advice, PRIME, Clinical trial Applications, Orphan Drug Designations, Pediatric Investigation Plans, and Development Safety Updated Reports. Federica also supports regulatory activities with the FDA, including participating in FDA meetings, Investigational New Drug applications and amendments, initial Pediatric Study Plans, Orphan Drug Designations, and more.
She will be presenting on:
IND Versus CTA Submissions: Is Your Drug Development Program Ready to Take on Both?
May 3, 2023 4:45 p.m., Stream A: Outsourcing & Clinical Operations