Paul Houston – Head of European Operations
Paul Houston heads up CEF activities and projects, serving as a liaison to Innovative Medicines Initiative (IMI) and European Medicine Agency (EMA) and overseeing the CDISC Europe Research Team. Mr. Houston is a co-lead of the standards advisory group, which is part of the IMI’s Translational Research repository, eTRIKS, and represents CDISC on the IMI BioVacSafe consortium, which is developing a new vaccines standard. He also sits on the CDISC UK User Network and the Europe CDISC Coordinating Committee (E3C).
Before joining CDISC, Mr. Houston served as a Programme Manager in International Standards at the EMA standards activity in the ICH, CDISC, HL7 and ISO spaces. Taking the project lead on the Identification of Medicinal Products standards, he worked closely with the pharmacovigilance departments at FDA and PMDA to publish the Identification of Medicinal Products (IDMP) suite of standards to be implemented by EMA, FDA and PMDA.
Dorina Bratfalean – Data Management Consultant
Dr. Dorina Bratfalean provides advice and guidance on CDISC standards on behalf of the CEF for the IMI projects, eTRIKS and BioVacSafe. Specifically, she implements and maps project data to CEF standards and provides each project with a data standards plan to ensure consistency, integrity, quality and harmonisation across clinical and non-clinical study data in translational medicine.