Falls Church, Virginia (PressExposure) July 30, 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...
Clear your calendar! "Rx Track and Trace Day" is Wednesday, Aug. 14 -- the day 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.
Plan on spending 5Â½ 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, will explain 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.
- Marketing technology guru David Dejean: Dejean, Vice President of Systech International for more than 20 years, is responsible for identifying and implementing customer requirements, staying abreast of international regulations, and implementing business solutions for growth and scalability of services.
- 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 daylong 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
Time to implementation is too short to organize a fly-in conference, but worry not. You'll participate from the convenience of your conference room, auditorium or very own desktop -- and never spend a dime on travel. No planes, no hotels, no precious time away from work and family -- just a day of solid, interactive learning.
Yes, interactive. Submit questions in real time via email. You'll get answers back by the time the session ends.
And here's more good news: Enlist your entire team at no extra cost. One low registration fee covers every participant at your location. It's easy to add additional locations too, at bargain rates. Simply call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about multisite discounts.
There's so much to learn about track and trace, counterfeiting and related issues ... and so little time to learn it ... you simply can't justify missing "Rx Track and Trace Day." Register now.
"Mastering Compliance with the California e-Pedigree Law"
This in-depth white paper, FREE to all virtual-conference attendees, explains how to comply with California's e-Pedigree law with analysis of the most troublesome areas, including:
- Handling drop shipments
- How to satisfy the coming 50 percent compliance deadline
- What level of inference will be allowed in receiving shipments
- How will trusted trading partners be defined
- Requirements for digital signatures
- Permissible level of aggregating multiple products in a single case
- What tamper resistance measures will be required for packaging
- How to satisfy certification requirements
Remember, your copy is FREE with your paid registration.
Pharmaceutical Track and Trace
From California to Congress, Implementation Concerns Grow
Aug. 14, 2013 -- 10:00 a.m. - 3:30 p.m. EDT
$1,297 per site -- includes virtual conference registration and audio cds and transcripts
4 EASY WAYS TO REGISTER
By phone: 888-838-5578 or 703-538-7600
Mail to: FDAnews, 300 N Washington St, Ste 200, Falls Church VA USA 22046-3431
Please forward this press release to colleagues who may want to read it.
FOR FURTHER INFORMATION, PLEASE CONTACT:
300 N Washington St, Ste 200
Falls Church, VA USA 22046-3431