# Presentation: 769132

## FDA Anti-Counterfeit WorkshopBuilding a Secure Supply Chain 

- Mike Meranda
- President, EPCglobal US

## EPCglobal Community

**Established** 		Nov-2003
**Mandate**		-  Develop user-driven technical standards for EPC
- 			-  Support adoption and implementation of EPC
- 			-  Leverage 30+ year expertise in managing globally 			   unique numbers (UPC and barcode)
**Principles****	****	**-  Not for profit standards organization
**	****	****	**-  User driven and governed (all supply chain roles)
**	****	****	**-  Public policy and regulatory support
- 			-  Direct, practical support for industry initiatives
- 			-  Key value driver is standardized data exchange
- 			-  Global implementation support (103 offices)
- 			-  Committed to working with government, industry
- 			   associations, other standards bodies
- 			-  Support large, medium and small companies
**Standards Work**		1,600+ global participants
**Subscribers**		800+ global subscribers

## EPCglobal Community

- 30 of top 40 global _**pharmaceutical manufacturers**_, 16 of top 20 US manufacturers
- 3 of top 4 _**retail pharmacies**_ and 4 of top 6 _**supermarket pharmacies**_ are part of EPCglobal (20,000 locations in total)
- 4 of top 5 _**medical devices**_ companies are current subscribers (10 of top 11 worldwide companies are registered for upcoming summit on 2-March in Princeton)
- 10 of top 11 _**hospitals**_ based on 2004 revenues registered for upcoming summit 21-March in Arizona

## EPC in the Healthcare Industry

- EPCglobal Healthcare Action Group formed in 2004
- Members represent:
- 30 of 40 largest global manufacturers
- 3 largest distributors
- 3 of 4 largest  retail pharmacies
- Formed in association with HDMA, NACDS, PhRMA and others
- Active participation in all key supply chain roles
- Manufacturers, Distributors, Retailers, Hospitals
- Focused on addressing critical needs:
- Pedigree Management (including a Pedigree Messaging Standard)
- Air Interface Standard for item level tagging
- Serialization (the format of the EPC on the tag)
- Decommissioning of tags
- Network Security
- EPCglobal helped form and supports the Unified Pedigree Coalition

## Safe and Secure Supply Chain

***EPC/RFID is the best available technology***
- Faster read capability
- Read and authenticate shipments with no “line of sight” needed
- Identifying expired items w/o handling each item
- Receipt of pallets and cases with out disassembly
- Reduced physical handling = reduced risk/increased security
- EPC takes advantage of best practices for data sharing
- Distributed data (data is held by owner)
- Lower cost to supply chain
- Industry actively moving towards standardization
- Item level Requirements complete
- EPCglobal Technology Demonstration March 23-24
- Development of new/modified standard

## Safe and Secure Supply Chain

***EPC and Public/Private Leadership***
- EPC created through public and private leadership
- Current EPC implementations by global leaders indicate long-term commitment
- RFID has already demonstrated applicability to solve critical regulatory issues
- Physics and standards challenges are being overcome
- Equipment prices are going down
- The community has moved decisively from preparation to implementation

## Safe and Secure Supply Chain

***Recommendations on Adoption***
- FDA
- Continue to drive toward one Pedigree Standard
- Focus on what’s most important first
- Phased approach to Serialization
- Industry Focus on critical Drugs vs. all at once
- Work with industry as they learn through Implementation
- E-Pedigree
- EPC/RFID
- Industry
- Continue to implement
- Share pilot experiences