Dr. Botond Katona
Dr. Botond Katona is a medical doctor with a background of public health and management.
He has been involved in the pharmaceutical industry since 2005, starting as a research scientist, quickly ascending to high-level positions.
He has an experience in designing and managing bioequivalence trials, which resulted in many successful DCPs and MRPs. As a member of the Bioequivalence Working Group of the EGA RSAC, he contributed to the revision of the Regulatory guidance for investigation of bioequivalence.
He has an experience of life-cycle management of the >3000 MAs for >200 products in >100 countries world-wide, comprising of innovative, “abridged” (i.e. generic, “hybrid”) and well established use medicines, as well as food supplements and medical devices. Besides ”routine” regulatory procedures he is experienced also in management of OTC switches, PIP waivers.
He has further managed development of a number of pharmaceutical products; manufacturing technology transfers; and also supported in-licensing of many products through dossier-due diligences; has organized structures to cope with Regulatory Affairs and Pharmacovigilance.
Acts as Research and Development Director and Managing Director of AccepTher since founded.