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Ottawa Marriott Hotel

Oct 18, 2016 8:00 AM - Oct 19, 2016 4:00 PM

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA Annual Canadian Meeting 2016

Explore how innovation can support new initiatives, regulatory processes, research, transparency, engagement, personalized medicine, and use of real-world data in Canada.

Session 3 Track C: Science and Product Development

Session Chair(s)

Laura  Durno, MS, MSc

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)

Anthony  Mire-Sluis, PhD

Interacting with Regulators to Facilitate New Technologies in the Biotechnology Industry

Anthony Mire-Sluis, PhD

Astrazeneca, United States

Head of Global Quality

Marzena  Ingram

Product, Process Understanding, and Statistical Process Control: PV Life Cycle Approach

Marzena Ingram

Apotex Inc. - Signet, Canada

Manager, Process Validation, GSO- Technical Operations Validation

Daniel L Keene, MD, MA, FRCPC

Speaker

Daniel L Keene, MD, MA, FRCPC

Health Canada, Canada

Associate Director, Office of Clinical Trials

Catherine  Njue, PhD

Speaker

Catherine Njue, PhD

Health Canada , Canada

Manager, Office of Biostatistics

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