Regulatory toxicology, pharmaceutical nonclinical development, medical devices, prions & TSE, foods, food irradiation, & food additives. Safety & risk assessments, due diligence, expert witness. CRO selection, advice on study programs, monitoring, & reviewing study reports. Preparation of regulatory documents.
Experience
25 Years in CROs as scientific director, team leader, department head, project director, principal toxicologist, director of pharmaceutical toxicology, & scientific director in UK & in Denmark.Nine year's as Executive Director of Nonclinical Development at a pharmaceutical company in Denmark.Regulatory submissions in N.Am, Europe, Japan & Australia.
