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Session 3 Track C: Science and Product Development
Session Chair(s)
Laura Durno, MS, MSc
Acting Chief, Viral Vaccines Division
Biologics and Genetic Therapies Directorate, Health Canada, Canada
Developing and implementing new technologies, manufacturing processes, and clinical trials in the biotechnology industry requires an understanding and cooperation between the innovator and the regulator. The session will discuss the challenges and conversations that need to happen between both parties in regards to innovative approaches in order to advance a product through clinical development and, ultimately, to market.
Speaker(s)
Interacting with Regulators to Facilitate New Technologies in the Biotechnology Industry
Anthony Mire-Sluis, PhD
Astrazeneca, United States
Head of Global Quality
Product, Process Understanding, and Statistical Process Control: PV Life Cycle Approach
Marzena Ingram
Apotex Inc. - Signet, Canada
Manager, Process Validation, GSO- Technical Operations Validation
Speaker
Daniel L Keene, MD, MA, FRCPC
Health Canada, Canada
Associate Director, Office of Clinical Trials
Speaker
Catherine Njue, PhD
Health Canada , Canada
Manager, Office of Biostatistics