Holds more than 25 years’ experience from the Pharmaceutical industry within the CMC area.
Experience working with both active pharmaceutical ingredients and medicine products for the European and American market, according to guidelines, ICH guidelines and the Pharmacopoeias (EP, PB, DLS and USP).
Broad experience within validation of analytical methods according to ICH Q2 (R1) and verification of monographs. Have been a tutor both at Pharmacon and at the MIND education under the university, lecturing in QC and analytical validation.
Experience working with registration files for the European and the American market both writing sections of the file and as an assessor within the Danish Medicines agency. Have been a part of the planning and execution of an advisory committee meeting as a part of the FDA registration process.
Experience from small development companies working in project teams and from quality control in larger setups. Always under GMP. Have also functioned as leader of an analytical development laboratory for several years.
Experienced in working with, CRO’s and Tech Tranfer.
Have held inspections both as an analytical expert within the Danish medicines agency and as a company representative. Have also functioned as an auditor for internal and external audits.
Torben holds a master’s degree in chemical engineering.
GMP, Quyality guidelines, Quality systems, HPLC, Dissolution, Analytical validation, Analytical development, Inspections, Audit,