의약품 공급망 보안

The ineffective management of supply chains by manufacturers and distributors has allowed counterfeiters and smugglers to evolve rapidly and become very creative and excel in producing counterfeit medicines and inserting them into the legitimate supply chains, meaning that many fake medicines go undetected. To counter this issue, global organizations, such as the World Health Organization (WHO), the European Union (EU), and the US Food and Drug Administration (FDA), work together to protect the safety and security of patients through pharma supply chain security.

Evolution in Supply Chain Management

DSCSA (Drug Supply Chain Security Act) established a 10-year roadmap with enforcement and adaptations in 2015 and 2018 related to Product Tracing, Product identifiers, Authorized Trading Partners, and Verification. The last section of the law, is Electronic Drug Distribution Security (EDDS). Among other things, EDDS directs all trading partners to have in place a secure, electronic, and interoperable system for the exchange of transaction documentation [transaction information (TI) and transaction statements (TS)] to enable the tracing of prescription medications.

Features:

• Graphs, charts, tables and visualizations complement the analysis
• Forecasts, projections of future market activity are derived using standard modeling and statistical techniques.

What You Will Learn:

• Provides detailed analysis DSCSA strategies, and workflow component factors.
• Assesses key stakeholders, market dynamics and market demographics.
• Analyzes therapeutic demand drivers and evaluates readiness in key supply chain segments.
• Provides market data and forecasts.
• Profiles market sector participants, their market activities, business strategies, and corporate alliances and affiliations
• Assesses the importance of alliances and partnerships on DSCSA implementation.
• Evaluates the impact of supply chain security economic, technology, and regulatory factors.

Table of Contents

• Executive Summary
• Pharma Supply Chain Security
• Executive Summary
• Drug Safety vs Drug Security
• A Paradigm Shift in Healthcare Integrity
• DSCSA Objectives
• DSCSA Implementation
• Overview of Product Tracing
• Track and Tracing
• Threats to Drug Security
• Counterfeiting
• Packaging for Drug Security
• Track and Trace
• Tamper Evident Packaging
• Enabling Drug Security Technologies
• Serialization
• Bluetooth
• Wireless Options for Drug Security
• Near Field Communication
• RFID
• Wireless Architectures
• Digital Healthcare and Cybersecurity
• Medical Applications for NFC
• UDI
• Hospital Inventory Tracking Solutions
• In-patient Management
• Threats to Drug Security
• Physical Security
• Blockchain
• Counterfeiting
• Optical variable devices
• Watermark
• Security threats
• Security foils
• Optically Variable Inks/Color shifting Inks
• Intaglio printing
• Laser marking
• Magnetic strip
• Micro/nano printing
• Hidden imagery
• Polarization imagery
• Security inks
• Nanoparticles
• Packaging for Drug Security
• Drug Distribution Security
• Track and Trace
• Unit Dose Packaging
• Holograms
• Optically Variable Ink
• Color Shifting Inks
• Enabling Drug Security Technologies
• Interoperability
• Serialization
• Regulations
• The Drug Supply Chain Security Act (DSCSA)
• DSCSA Requirements for Pharmacies and Retail Entities
• United States Legislative Programs
• Automation of Reports and Consolidated Orders System (ARCOS)
• EU Falsified Medicines Directive
• Cost Estimates and Forecasts
• Market Participants
• AlpVision
• Packaging and label protection
• Angstrom Technologies
• Advast Suisse AG
• Covectra
• LGPM Pharma
• Korber
• NucTech
• Imaging and Sensing Instrumental Methods
• RxScan
• TraceLink
• TrackTracerx
• VISIOTT Pharma Serialization Solutions
• Conclusion