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Ottawa Marriott Hotel

Oct 28, 2013 1:30 PM - Oct 28, 2013 5:00 PM

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

Trends in Health Canada Inspections

Speakers

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.

Julie  Calendino

Julie Calendino

Sr Corporate Regulatory Compliance & Enforcement Advisor, Health Canada, Canada

Linda  Jack, PhD

Linda Jack, PhD

Global Regulatory Franchise Head, Infectious Disease, Rheumatology and Gastroimm, Roche Products Ltd., United Kingdom

Linda Jack is currently Global Regulatory Franchise Head with responsibility for the infectious disease, rheumatology and gastroimmunology portfolio at Roche. She has >30 years industry experience with 25+ years in regulatory affairs, from UK and Ireland national activities through to Global Regulatory Leadership for individual products in a range of disease areas to portfolio-level responsibilities. Prior to her current role she spent several years as Director of Regulatory Affairs and Quality Management at Roche Canada. She began her career in the pharmaceutical industry in cardiovascular research and as a DMPK study director before moving to regulatory.

Andrei  Baume

Andrei Baume

Senior Compliance Specialist, Drug GMP Inspection Unit, Health Canada, Canada

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