OLEKSANDR KARPENKO, Director, Olexacon

•   Oleksandr Karpenko is a pharmaceutical physician, clinical and medical safety consultant and MD with Olexacon (London, UK). In his consulting projects Oleksandr leverages expertise and skills gained over 18 year of hands-on and management experience with Roche, AstraZeneca, Takeda, Servier and other companies.

•   He has worked in medical capacity at various levels in global drug safety, from affiliate PV, global safety operations to global safety lead and therapeutic area head responsibility from preclinical to various stages of clinical and postmarketing safety surveillance.

•   His industry therapeutic expertise includes oncology, gastroenterology, respiratory, metabolism, inflammation, and other areas. Oleksandr has MBA and MD degrees, with initial medical specialization in orthopaedics and traumatology, including 4 years of practicing medicine, licensed for practice in the UK.

•   Oleksandr provides medical contribution to a range of services, including medical monitoring and data review, safety oversight of investigational and marketed products, signal detection and evaluation, risk management, safety contribution to design of clinical development programs and individual clinical trials, contribution to pertinent clinical documents and reports (IB, IMPD, study protocol, ICF, CRF, clinical study reports etc.) processes and decision criteria (safety reporting, stopping rules, go-no go criteria etc.), Data Monitoring Committees, training of investigators and service provider personnel.

•   Oleksandr also leads from the medical safety perspective regulatory submissions (NDA, BLA, marketing authorisation applications), periodic and aggregate reports (PSUR/PBRER, DSUR, CTD 2.5 and 2.7.4, ACO, PADER etc.), as well as Risk Management Plans (RMPs), responses to regulatory requests and other regulatory interactions, ICSR medical review and other services.