Asset Visibility: Pharma Industry Track and Trace Regulations in North America
Price: Starting at USD 3,000
Publish Date: 11 Feb 2022
Code: PT-2569
Research Type: Presentation
Pages: 23
RELATED SERVICES:
Actionable Benefits
- Strategic planning for pharmaceutical vendors and distributors for changes in serialization regulations.
- Gain insight into scale and scope of regulations.
- Guidance into proposed future regulatory changes.
Research Highlights
- Regional focus on North America (US and Canada).
- Identifies variation between North American regulations and other regions.
- Comparison and analysis of different levels of traceability.
Critical Questions Answered
- What is the timeline for implementation of serialization regulations?
- What are the key data standards and mandates for traceability?
- How are international standards like GS1 leveraged in national regulations?
Who Should Read This?
- Strategy planners and advisors within the pharmaceutical and supporting logistics industry.
- Managers aiming to identify regulatory requirements of their operations.
- For serialization software and hardware providers to assess regulatory impact on the pharmaceutical market.
Table of Contents
Executive Summary
Global Regulatory Environment
Regional Regulatory Environment
Key Objectives
National Regulations and International Standards
Summary of Proposed System
Compliance: Mandates versus Voluntary Best Practices
Reporting Requirements
Suppliers and 3PLs Responsible for Track & Trace (T&T)
Good Distribution Practices
Legal Enforcement
Scale and Scope of Implementations
Items Subject to Track & Trace (T&T)
Future Amendments Proposed
Regulatory Timeline
Serialization Data Tables
Definitions and Abbreviations
Related Research
Asset Visibility: Pharma Industry Track and Trace Regulations in Asia-Pacific
Presentation | 2Q 2022 | PT-2577
Asset Visibility: Pharma Industry Track and Trace Regulations in the Rest of the World
Presentation | 2Q 2022 | PT-2571
Asset Visibility: Pharma Industry Track and Trace Regulations in Europe
Presentation | 1Q 2022 | PT-2570
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