Pharmaceutical Serialization 101
- Coming soon!
Our zero-to-hero introduction to pharmaceutical serialization.
Everybody should feel safe when they get medicine from a hospital, pharmacy, or approved online pharmacy.
Serialization affects many functions, at stakeholders across the pharmaceutical supply chain, with different requirements in global markets.
Pharmaceutical Serialization 101 - designed to upskill teams across departments, from regulatory to IT, compliance to Business Development.
Pharmaceutical Serialization 101 will align knowledge and streamline communication across your organisation and beyond. Empower your workforce to work smarter, not harder. Say goodbye to costly misunderstandings and delays, and hello to faster delivery, sharper execution, and greater efficiency.
It’s not just training - it’s a strategic upgrade for your entire organisation!
Overview
A comprehensive introduction to the legal requirements and business impacts of the US DSCSA, European Union's Falsified Medicine Directive and more.
Multiple global requirements
There's no unified standard for pharmaceutical serialization: regulations, timelines and systems vary across the globe.
The United States' Drug Supply Chain Security Act (DSCSA) and the European Union's Falsified Medicine Directive present two very different approaches to safeguarding patients. Across the globe, there are many other regimes in force, with even more on the way.
Operational complexity
Putting pharmaceutical serialization into practice is complex: it requires multiple functions at every organisation in the pharmaceutical supply chain.
Serialization requires an overall business strategy that considers all the organisational, and cross-organisational implications.
How Pharmaceutical Serialization 101 will help:
Pharmaceutical Serialization 101 provides a high-level overview of pharmaceutical serialization. We’ll cover:
- the key regulations driving its implementation
- the technical systems that make it work; and
- how all this impacts operations.
Modules and timings
We offer three clear, concise modules covering different pharmaceutical serialization topics.
Pick the right solution for your organisation: Module 1 + Module 2 and/or Module 3:
Module 1
Introduction to Pharmaceutical Serialization
The core principle of pharmaceutical serialisation - unique identification - is universal, but it’s not the whole story. Serialization provides the foundations for a range of other processes, including:
- tracking and tracing
- verifying
- reporting
Approx. 15 minutes
Module 2
The United States: the DSCSA
The United States' Drug Supply Chain Security Act (DSCSA) establishes an enterprise-run, transaction-focused approach that tracks and traces prescription drugs as they move through the supply chain, particularly when they change ownership.
Approx. 15 minutes
Module 3
Europe: the EU Falsified Medicines Directive
The European Union's Falsified Medicines Directive (EUFMD) requires serialization of prescription drugs, to establish near real-time verification against a centralised repository system.
Approx. 15 minutes
Who's it for?
Pharmaceutical serialization touches many roles across the supply chain:
Organisations
Organisations who need to master pharmaceutical serialization include:
- Pharmaceutical companies
- Manufacturers
- Contract Manufacturing Organisations (CMOs)
- Third-Party Logistics Providers (3PLs)
- Wholesalers
- Distributors
- Dispensers, such as hospitals and pharmacies
People
People with a role to play in pharmaceutical serialization include:
- IT
- Regulatory and Compliance
- Supply Chain Management
- Data Management and Analytics
- Operations
- Packaging
- Quality
- Business Development
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