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Session 7 - Hot Topics in Canada
Session Chair(s)
Mark Collins, PhD, MBA
Principal Consultant
Opus Regulatory, United States
In this session, plain language labeling will be discussed. Speakers will highlight the draft, published regulations concerning plain language labeling, an attempt to make drug labeling understandable by focusing on five targeted amendments which will provide: 1) a requirement for clear understandable, plain language labels; 2) required label mock-ups at time of review; 3) look-alike, sound-alike brand name assessments; 4) label contact information to report problems; and 5) a standard table format for key label information for nonprescription drugs. This session will also cover the final guidance, Labeling of Pharmaceutical Drugs for Human Use, highlighting changes from the 2010 draft and key points.
Speaker(s)
Hot Topics in Canada: Draft Plain Language Labeling Regulations
Bruce Boulton, MSc
Health Canada, Canada
Product Information Officer, Bureau Gastroenterology, Infection & Viral Diseases
Final Guidance – Labeling of Pharmaceutical Drugs for Human Use
Bruce Boulton, MSc
Health Canada, Canada
Product Information Officer, Bureau Gastroenterology, Infection & Viral Diseases
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