Dr. Karsten Roth

Director Clinical Operations & Pharmacovigilance

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Karsten Roth leads the clinical development and pharmacovigilance teams at Cinfa Biotech. He is responsible for the development and implementation of preclinical, clinical and post-approval clinical activities and oversees the pharmacovigilance activities at Cinfa Biotech. Karsten has over 22 years of experience in the pharmaceutical industry, having held various international executive positions with a strong focus on clinical development and medical affairs across several therapeutic areas. In his former positions, he contributed to several Biosimilar marketing authorization submissions for the US and EU, presentations at FDA, PMDA and EMA meetings, and was involved in setting up and leading global advisory boards. Karsten holds a PhD in biochemistry, a postgraduate degree in pharmaceutical medicine and a Master in project management from the George Washington University.