Jun Zhang Email & Phone Number

More than 30 years’ education and experience in clinical medicine, epidemiology, biostatistics, public health, risk evaluation, and benefit-risk assessment, and 15 years’ experience in evaluation of efficacy and safety of therapeutic products within the framework of the Food and Drug Act and Regulations, with demonstrated abilities to:1. Conduct drug submission review, health risk assessments, and evaluation of other health related issues:• Lead/conduct benefit/risk assessment of therapeutic product submissions within the Health Canada performance standard, and according to the submission plan as applicable.• Complete assessment work including health risk management activities, medical necessity assessments, and media requests in a timely manner.• Write review documents, make scientifically-sound evidence-based regulatory recommendations2. Maintain scientific and regulatory expertise and awareness• Maintains scientific expertise related to scientific and review skills through literature review, training, discussions with section head/manager and colleagues, and other educational activities.• Maintains awareness of regulatory context through monitoring and consideration of emerging trends, international guidelines and the activities of international regulators. • Maintains organizational awareness through regular and active participation in Bureau, Directorate and Branch activities where possible.

Listed skills include Clinical Trials, Benefit Risk Assessment, Therapeutic Products, Respiratory Therapy, and 8 others.

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  Clinical Reviewer

  Health Canada

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  West-China Medical University, Queen'S University

  Clinical Medicine, Preventive Medicine, Clinical Epidemiology