Anja Slikkerveer (MD PhD ERT) is a pragmatic drug development professional with over 30 years’ experience in nonclinical drug development. Being a physician (MD) and a toxicologist, she is very well equipped to work in translational science and assess potential clinical (side) effects.
In her career, Anja has championed the transition of numerous drugs from preclinical to phase 1 and participated in many scientific advice meetings with EMA and local authorities, and prepared Marketing Applications (MAA/NDA). Anja has been involved in all aspects of drug development, including designing and executing nonclinical drug development program’s (phase 0 to phase 4), Environmental Risk Assessment reports (ERA’s) and has submitted over 20 MAA’s.
She has a special interest in the safety assessment for drug substances and products, (solvents, [elemental] impurities, assessments of cleaning limits) as she was an EFPIA topic expert in the ICH Q3D Expert working Group.