Simplifying Global Compliance
Pharmaceutical Track and Trace From California to Congress, Implementation Concerns Grow
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Held Aug. 14, 2013
California is close to rolling out e-Pedigree. The FDA is cranking up scrutiny of Rx counterfeiting. Congress is hammering out new track and trace legislation. An entire new compliance area looms for drugmakers — for YOU. Ready … or not…it’s here…
Drugmakers get up to speed on implementation of the emerging prescription drug track and trace system.
FDAnews has invited top regulators from California and the FDA, plus industry experts, to brief YOU on this new set of compliance requirements.
Spend 5½ fast-paced hours with the brightest stars in the drug regulatory firmament, and industry too:
- Virginia Herold, California’s point person on track and trace: Herold, chief of the California State Board of Pharmacy, explains that state’s groundbreaking e-pedigree program, including details of the Board’s June 24 e-pedigree committee public meeting and what’s in store for the coming September 26 meeting.
- Industry track and trace guru Bill Fletcher: Conference Chair Fletcher, Managing Director, Pharma Logic Solutions, walks you through the 17 (18 and 19 pending!) company traceability program rollouts he has implemented at leading pharmaceutical companies, and imparts lessons learned.
- Gabrielle Cosel, The PEW Charitable Trusts: brings you the latest from Capitol Hill, where she monitors track and trace in the House and Senate. Ms. Cosel, manager of Pew’s Drug Safety Project, will preview what the final bill may contain and how Congress has set up the complex implementation schedule.
- Track and trace expert Torben Vogt: Vogt covers the bits and bytes of setting up a track and trace system in your shop. From the simple (allocating and randomizing serial numbers) to the complex (developing global systems that can work in the U.S., U.K., China and other nations), Mr. Vogt is ready with tips, tricks and shortcuts that help you implement track and trace with the least effort and expense.
Get set for an intense learning experience getting comfortable with this new drug distribution compliance area. Prepare to discover:
- Exceptions and exemptions to the California requirements
- Status of pending and future regulations to implement California’s e-pedigree requirements
- Federal regulatory frameworks for serialization and traceability
- Updates to pending House and Senate bills, and probability of passage
- Tracking registries (using EPCIS) versus e-pedigree document (using DPMS) for California compliance
- Difficulties and challenges of implementing a serialization and track and trace program
- How to minimize implementation cost of serialization and track and trace
- Best practices to minimize risk in implementation on a global scale
- And much more
Meet Your Faculty
- Bill Fletcher, Managing Director, Pharma Logic Solutions (Chair): With more than 28 years in pharmaceutical, enterprise software and healthcare systems under his belt, William (Bill) Fletcher is the right person to manage the day’s proceedings. A consultant specializing in track and trace, anti-counterfeiting and pharmaceutical serialization, he boasts expertise with packaging/labeling automation and inspection systems, serialization, barcoding, radio frequency identification (RFID), distribution systems, e-Pedigree/RxASN and supply chain track and trace to drug discovery and R&D, clinical trials, brand marketing and physician education. He has developed serialization and e-Pedigree strategy, requirements, vendor selection and project planning for multiple companies.
- Virginia Herold, Executive Officer, California State Board of Pharmacy: Virginia Herold has led the Board of Pharmacy since January 2007. Previously, she served as interim executive officer and assistant executive officer. As executive officer, Ms. Herold regulates over 130,000 licensees in 13 separate licensure classifications including pharmacists, pharmacies and drug wholesalers.
- Gabrielle Cosel, Project Manager, Drug Safety Project, The PEW Charitable Trusts: Cosel works on federal initiatives to ensure the safety and oversight of the U.S. pharmaceutical supply chain. Previously, Cosel worked on pharmaceutical safety and appropriate prescribing for national advocacy organization Community Catalyst, and in grassroots development with the Fund for Public Interest Research.
- Torben Vogt, Industry Expert, Life Science Solutions, NNIT: Torben is a Life Science Industry Expert with a background that includes Novo Nordisk Bioindustrial Group and global generics leader Actavis, where he was VP of IT. At NNIT, Vogt is responsible for a portfolio of serialization programs and drives the development of NNIT’s serialization and trace and trace services.
- Supply chain management
- Quality assurance staff
- Packaging personnel
- IT systems staff
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