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Pharmaceutical Labeling: Introduction to an Essential Function

2.0 RAC Credits Member: $255.00 Nonmember: $350.00
Pharmaceutical Labeling: Introduction to an Essential Function
This course provides an overview of healthcare product regulation across product lines in North America, specifically in the US and Canada. It highlights the agencies primarily responsible for regulating healthcare products—the US Food and Drug Administration (FDA) and Health Canada. The course highlights the applicable legislation that drives the regulatory processes.

Labeling is one of the most visible components of a healthcare product. It presents key information for the users that make it a powerful tool for treatment decisions. The scope of Labeling extends beyond the product information to include a number of important functions and deliverables that are not often appreciated, even by regulatory professionals.

This course introduces regulatory professionals who may have some familiarity with the function to those many touch points, responsibilities, and challenges of the work involved in healthcare product labeling. The Learner will gain the foundational understanding and vocabulary needed to discuss labeling matters in an informed way. The course also integrates scenarios that illuminate some of the practical challenges relating to the labeling of healthcare products. It also features video comments from labeling professionals currently working in the field. They animate the subject by sharing their perspectives on the role and relating some illustrative examples from their experience.

At a Glance
  • Target Audience: This course is designed to expand the understanding of regulatory professionals about the activities, documents, and responsibilities involved in labeling healthcare products.
  • Total Length of Course: 2 Hours
  • RAC Points: 2

Lesson Titles
  • Introduction
  • Section 1: The Importance of Labeling
  • Section 2: Labeling Development
  • Section 3: Labeling for Healthcare Professionals
  • Section 4: Core Labeling: Maintaining Global Consistency in Product Information
  • Section 5: Target Labeling
  • Section 6: Labeling for Patients
  • Cliffhanger Scenarios: What would you do?
  • Select Resources and examples

Enrollment Period: 12 months

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