Robert Hemmings, MS

Robert Hemmings, MS is currently partner at Consilium Salmonson & Hemmings and has deep expertise in global clinical trial design, critical appraisal of clinical trial data and regulatory affairs. He was head of the group of statisticians and pharmacokineticists at the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for nearly 20 years. He has been a member of the Committee for Medicinal Products for Human Use (CHMP) at the EMA for 11 years, has chaired EMA’s Scientific Advice Working Party 8 years, and chaired and served on EMA’s groups for biostatistics, modelling and simulation and extrapolation. Hemmings also represented the EU and was the Rapporteur for the revision of the ICH guideline E9 (R)1 addendum on estimands and sensitivity analysis in clinical trials, to the guideline on statistical principles for clinical trials. Additionally, he has involvement in multiple initiatives related to innovation in clinical trial design and regulatory strategy including, EMA’s Priority Medicines (PRIME) scheme for unmet medical needs, adaptable pathways, and accelerated access pathways in the UK.