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Ottawa Marriott Hotel

2016 年 10 月 17 日 8:30 上午 - 2016 年 10 月 17 日 12:00 下午

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

Course 1: Plain Language Labeling: Implementing Health Canada’s Guidance for Industry

Instructors

Rebecca  Bose

Rebecca Bose

Policy Division-Policy Science Int'l Programs, Therapeutic Products Directorate , Health Canada, Canada

Sonya  DaCosta, RN

Sonya DaCosta, RN

Regulatory Affairs Labeling Manager, Apotex Inc., Canada

Sonya DaCosta is a Regulatory Affairs Manager of Labeling for the Canadian and US markets at Apotex Inc. She oversees generic labeling of submissions and commercialization of labels for New Products, Marketed Products and Private Label Consumer Products. Sonya has over 15 years of experience in Regulatory Affairs at Apotex and works closely with the RA Affiliates, Pharmacovigilance, Medical Affairs, Quality and Marketing in her organization to ensure labeling is safe, effective and clear to health care professionals and patients.

Christine  Leroux

Christine Leroux

Senior Regulatory Project Manager, Health Canada, Canada

Veronica  Yip

Veronica Yip

Acting Manager, Labelling Division, Health Canada (TPD), Canada

Veronica Yip has over 13 years of Canadian pharmaceutical regulatory experience. As the Manager of the Labelling Division in the Therapeutic Products Directorate (TPD), she is currently responsible for advancing TPD's current and future drug label review mandate and delivery objectives. Ms. Yip previously worked as a Labelling Reviewer for three years with the Bureau of Pharmaceutical Sciences. She has also served as Acting Manager of the Regulatory Project Management Division in TPD; and Senior Regulatory Manager for various review bureau. She holds a Honours Bachelor of Science in Human Biology from the University of Toronto and a Post-Diploma in Regulatory Affairs and Quality Operations.

Rocelyn  DelCarmen

Rocelyn DelCarmen

Director, Regulatory Affairs and Quality Assurance, Astrazeneca Canada Inc., Canada

Rocelyn DelCarmen has 19 years experience working at various Canadian innovative pharmaceutical companies working primarily in the Regulatory Affairs-Quality Assurance areas, in addition to exposure to the reimbursement and sales areas. Rocelyn sits on the Regulatory Affairs committees at BIOTECanada and Innovative Medicines Canada.

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