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Ottawa Marriott Hotel

Oct 29, 2018 1:00 PM - Oct 29, 2018 5:00 PM

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

Short Course 2: Regulatory Renewal: Statistical Principles as Part of Regulatory Decision-Making


Catherine  Njue, PhD

Catherine Njue, PhD

Manager, Office of Biostatistics, Health Canada , Canada

Dr. Catherine Njue is the manager for the Office of Biostatistics in the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), Health Canada. In this position, she leads the biostatistics team that is primarily involved in evaluating the statistical methodology of clinical trials and other sources of evidence for biologics (e.g., vaccines, blood products) and related biotechnology products and radiopharmaceuticals. She also provides statistical expertise in the drafting, review and implementation of standards and guidelines developed by Health Canada, ICH, and WHO working groups.

Andrew  Raven, MSc

Andrew Raven, MSc

Manager for Biostatistics, Epidemiology, and Pharmacometrics Unit, HPFB, Health Canada, Canada

Andrew Raven joined Health Canada in 2004. He holds a Bachelor of Science in Molecular Biology and Genetics and a Master of Science in Mathematics and Statistics both from the University of Guelph. He has previously worked as a biostatistician and senior biostatistician, assessing study design and conduct as well as statistical methodologies and analyses in pre-market prescription drug submissions at the Therapeutic Products Directorate (TPD). He has been manager of the Biostatistics, Epidemiology, and Pharmacometrics Unit of TPD since 2015.

Melanie  Poulin-Costello, MSc

Melanie Poulin-Costello, MSc

Dir Biostatistics, Hoffmann-La Roche Ltd., Canada

Melanie Poulin-Costello is the Head of Biostatistics at Roche Canada with close to 20 years experience as a biostatistician in drug development. She is passionate about upskilling scientists’ statistical literacy and frequently teaches and discusses statistical concepts. Melanie has degrees from UVictoria and UWaterloo. She spent time living in China. Now, Melanie lives in Georgetown, ON and spends her free time painting and drawing with the local arts community.

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