As the Director of the Evaluation of Radiopharmaceuticals and Biotherapeutic Products at Health Canada, Dr. Klein gives a brief background on the introduction of the Food and Drug Act in Canada, followed by a full explanation of the regulatory process for biomarkers in Canada. The regulatory body focuses on the quality, safety and efficacy of diagnostic, preventative and therapeutic agents, being constantly evaluated from first discovery through market use to further evolution and all steps between.
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Taking novel imaging probes from discovery in a lab setting, through full development and on to manufacturing and clinical trials is one of the goals of the MITNEC program and the Centre for Probe Development and Commercialization. Dr. Valliant, the leader of the CPDC and a collaborator in MITNEC outlines each stage in this process, describing all of the steps involved. In particular, new probes in development for imaging neurologic disease are discussed.
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Taking novel imaging probes from discovery in a lab setting, through full development and on to manufacturing and clinical trials… Read More
As the Director of the Evaluation of Radiopharmaceuticals and Biotherapeutic Products at Health Canada, Dr. Klein gives a brief background… Read More