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Course

Toronto

Date:	Name:	Location
Wednesday, June 17, 2009 9:00 AM TO 4:00 PM (Registration 8:30 AM)	Regulatory Compliance for Biologics in Canada COURSE FULL	NEW LOCATION! Four Points Toronto Airport 6257 Airport Road Mississauga, Ontario (905) 678-1400
Fees:	Registration Link:	Registration Deadline
PSG Member: $295.00 + $14.75GST = $309.75 Non-Member: $375.00 + $18.75GST = $393.75	Registration for this course is currently closed.	Friday, June 12, 2009
Course Objective:
This 1-day course will provide: An overview of the Canadian regulatory requirements pertaining to Biologics. An overview of the manufacturing and testing requirements for Biologics.
Course Description:
This course will cover the following topics: Overview of the current Canadian Regulations which pertain to Biologics Review of the Progressive Licensing Framework, and how it pertains to Biologics Development Process for Biologics Overview of Manufacturing and Testing for Biologics Challenges from a Regulator Perspective Lot-Release Process for Schedule D compounds On-Site Evaluations Yearly Biologic Product Report Overview of the post-NOC changes quality guidance document
Course Leader:
Hugo Hamel, B.Sc., M.Sc. Hugo Hamel graduated from the University of Montreal with a B.Sc. in Biochemistry, a M.Sc. in Molecular Biology and a M.Sc. in Pharmaceutical Sciences. Since 2003, Mr. Hamel is a Senior Biologist/Evaluator with the Monoclonal Antibodies Division of BGTD. He is involved with reviewing the Chemistry, Manufacturing and Controls information pertaining to Clinical Trial Applications (CTAs), New Drug Submissions (NDSs) and Post-Marketing changes associated with Biotherapeutics. He is also the BGTD lead on the Post-NOC (Quality) Guidance working group. Prior to these duties as evaluator, Mr. Hamel spent two years with the Regulatory Affairs Division in BGTD as Submission Screening Officer and A/Unit Head, Biotherapeutics and Radiopharmaceuticals.
Who Should Attend:
This one day course is intended for individuals working in the areas of Regulatory Affairs, QA/QC, R&D, and Manufacturing Operations.

Health Canada/Santé Canada • U.S. Pharmacopeia (USP)
Canadian Association of Professional Regulatory Affairs/Association canadienne des professionnels en réglementation (CAPRA/ACPR)