Canada’s Regulatory Modernization Project Progress and Implications
Session Track: Opening Session
Date: Thursday, December 6, 2012; 2:20 – 3:35 p.m.
This session will provide you with a comprehensive view of the development and business impact of Canadian regulatory modernization. Through this session, you will identify key implications of the regulatory modernization project, interpret how changes or proposed changes will impact your company’s business, and learn how to refine processes within your organizationo meet Canadian standards and regulatory requirements.
Dr. William Yan, Director, Bureau of Nutritional Sciences, Health Canada
Dr. Yan obtained his Master degree in Microbiology and Ph.D. degree in Medical Microbiology and Infectious Diseases from the University of Alberta. He completed his post-doctoral training at Tufts University Medical School, Boston, MA in 1992. Dr. Yan has held progressive management responsibilities at Health Canada since 1999. He was Head of the Office of Biotechnology, Food Directorate, from 1999-2002, Chief of the Evaluation Division, Bureau of Microbial Hazards, from 2002-2008 and Director of the Health Effects Division of the Pest Management Regulatory Agency from 2008-2009. In June 2010, Dr. Yan was appointed as Director of the Bureau of Nutritional Sciences in the Food Directorate.
Lewis Retik, Partner, Gowlings
Mr. Retik practices primarily in the area of corporate commercial and regulatory law, and is co-chair of the Food, NHP, and Cosmetic industry group. Lewis' practice focuses on regulatory and commercial issues relating to the commercialization of products, including product distribution, manufacturing, advertising, packaging and labeling, and regulatory licensing. Lewis has extensive experience working with companies of all sizes, ranging from recent start-ups to large international companies in a variety of specialized industries, including technology, pharmaceutical, natural health products, food, and cosmetic industries. Lewis also provides advice to companies with regulatory compliance issues and the status of their products.
Scott Sawler, Director General, Natural Health Products Directorate, Health Canada
Prior to his current role, Mr. Sawler served as the Senior Manager of the Ethics and Regulatory Office for the NCIC Clinical Trials Group, a cooperative oncology group at Queen’s University. He worked for a number of years in industry and health care associations. He has gained extensive experience in regulatory framework development, consultations and stakeholder relations, and business management, to name a few. Scott spent twelve years in regulatory affairs at Schering-Plough, the Non-prescription Drug Manufacturers Association of Canada, Medis Health, along with other industry associations..
Anthony Pavel, J.D., Partner, Morgan, Lewis, & Bockins LLP (Moderator)
Mr. Pavel provides regulatory counseling to clients on food, drug, and cosmetic and medical device products. He has a broad range of experience with issues involving product claims in labeling, advertising, and other promotional material, as well as clinical research and substantiation issues, and regulatory strategies for functional foods and dietary supplements. Mr. Pavel also assists clients with novel food and color additive petitions, food packing and labeling, Food Contact Notifications and secondary food additives (packaging, processing aids), food safety compliance, HACCP, SSOPs, GMPs, and GRAS self-affirmations and notifications.