E. Rook: EMEA position on Pediatric Formulation and Dose selections
Dr Elisabeth J. Rook, MD PhD, epidemiologist, has been employed as a Senior Clinical Assessor at the Dutch Medicine Evaluation Board (MEB) since 2004. The MEB has a top-5 position in participating in centralized procedures as Rapporteur for other member states. The main focus of her daily work is the assessment of Pharmacokinetic & Pharmacodynamic data from registration dossiers of both new and registered
Dr Rook is a member of the drafting group for EMEA guidances on the treatment of HIV/viral diseases.
Hands-on experience with Modeling and Simulation of PK –PD data was obtained during several PhD research projects, resulting in several publications and a thesis (“Pharmacokinetics and Pharmacodynamics of Diacetylmorphine in Opioid Dependent Patients’’, Utrecht University, 2004).
Dr Rook is also a Clinical Expert in the field of pharmacological treatment of substance dependence and opioids. On behalf of the EMEA-EWP, Dr Rook is the leading Expert in the development of the recent EMEA Guideline on the Development of Medicinal Products for the Treatment of Smoking.