Dr. Lutz Wevelsiep
VP of Regulatory Affairs
AntiBioTX
Denmark
Biography
Dr. Lutz Wevelsiep, Ph.D. is the Vice President of Regulatory Affairs in AntibioTx and has more than 25 years’ experience in international Regulatory Affairs across Europe and the US within multinational and start-up companies. His experience includes EU decentralized and centralized procedures, product development from Phase I through to marketing authorization as well as particular expertise in anti-infectives. He has prepared and managed various health authority interactions with FDA, EMA and EU national agencies. Lutz has spent 16 years as Head of Global Regulatory Affairs at Basilea Pharmaceutica. His track record includes successful completion of the European marketing authorization applications for Isavuconazole (Cresmba®), Ceftobiprole (Zevtera®) and Alitretinoin (Toctino®). Lutz holds a Ph.D. and Postdoc in chemistry from the Max-Planck Institute in Germany
Research Interest
management
