It is time to look at the better healthcare supply chain conferences coming up this fall. This year the focus will be on the Drug Supply Chain Security Act (DSCSA) and the Unique Device Identification (UDI) final rule implementations. For the DSCSA I think we will see presentations aimed at both the immediate 2015 data exchange requirements and those aimed at the 2017 serialization requirements, but I also expect to see presentations aimed at “second generation” data exchange—those based on GS1’s recently updated Electronic Product Code Information Services (EPCIS) standard. After meeting the initial data exchange requirements for Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS) in January, companies will need to begin preparing for the second generation using EPCIS (see “DQSA: Getting To Electronic Transaction Data Exchange”). That transition will likely occur over the next three years.
For UDI I think we will see presentations focusing on number issuing agencies, proper UDI labeling and electronic filing through the FDA’s Global Unique Device Identification Database (GUDID). We should also hear reports of how meeting the first major deadline has gone for companies who make Class III medical devices. Their deadline for meeting the law is September 24 of this year (see “UDI Deadline For Class III Medical Devices Quickly Approaching”). Life supporting and life sustaining medical devices have one more year, Class II medical devices have another two years and Class I medical device have four more years to meet the final rule (see “FDA Posts Small Entity Compliance Guide For UDI and GUDID”).
It should be a good series of events. If you see me at one of these events, please introduce yourself.
Here are the events that have caught my eye for one reason or another, in chronologic sequence:
LogiPharma, September 16-18, Princeton, NJ
This annual conference focuses on topics related to pharmaceutical supply chain management, including serialization and track & trace from a manufacturer’s perspective. Speakers include those who lead the supply chain organizations of major pharma manufacturers. I like it because it attracts people whose job it is to figure out how to maximize the use of mandated serialization for both regulatory and ROI purposes. RxTrace is a media partner again this year. There is an early-bird savings so I recommend that you register before the end of August when it runs out. Pharma manufacturers should use discount code “LP2014RXTRACE” and save 25%! See you there.
Partnership For Safe Medicines Interchange 2014, September 17, Washington DC
I have attended every PSM Interchange event since they started in 2010. Every year it is a little different. That first event featured speakers and panels that expressed the problem of counterfeit drugs in the U.S. supply chain that had existed in the early 2000s but had largely been resolved five years earlier (see “DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 1”). More recently it seems to be focusing more on the problem of rogue websites that sell counterfeit and substandard drugs without requiring a prescription, but several speakers also look at problems in the regular supply chain. It will be interesting to hear speakers this year, now that the DSCSA is a reality and its enforcement is right around the corner. Be aware, this is not a technology event but more of a policy event, where “solutions” are strictly policy, regulatory and enforcement. RxTrace is again a media partner for this event and I plan to attend. Make sure you sign up TODAY because early-bird ends TODAY. See you there.
Dental Trade Alliance (DTA), Unique Device Identification (UDI) Workshop, October 8, 2014, San Antonio, TX
I will attend and speak at the Dental Trade Alliance UDI Workshop. The DTA is the trade association for manufacturers and distributors of medical device and drugs in the dental supply chain. Even though it is a UDI workshop, I’ve been invited to speak about the DSCSA as it applies to pharmaceuticals that are in the dental branch of the supply chain. Should be interesting.
Healthcare Supply Chain Association (HSCA) Expo, October 15-17, Washington DC
HSCA is the industry association for the Group Purchasing Organizations (GPOs). This year I have been invited to speak at the HSCA Expo about the DSCSA and serve on a panel discussion with Jay Crowley, formerly with the FDA and now a consultant with USDM. We’re going to talk about the implications of the DSCSA, the UDI final rule and Meaningful Use to hospitals. This should be an interesting session.
GS1 Healthcare Conference, October 21-23, Copenhagen, Denmark
I don’t think I’m going to be able to attend this event in Denmark but I’m still undecided. These GS1 Healthcare conferences are always highly recommended by me because they focus on the use of GS1 standards to solve regulatory and non-regulatory problems in healthcare supply chains. I’ve called these conferences “non-technical” in the past and have been chastised by friends who insist they are too technical for them. I still disagree and encourage non-technical people to attend. You will learn a little technology, but it is always couched tightly in the healthcare domain. The question I am grappling with is, do I need to attend more than one of these per year? I just attended the one held in the U.S. in the spring. GS1 standards are at the center of the solutions needed to meet the U.S. UDI and DSCSA regulations so if you did not attend the conference in the spring, this is the one for you. Next spring the event will be held in Mexico City. Let me know if you plan to attend the one this fall.
UDI Conference, October 28-29, Baltimore, MD
This fall’s UDI Conference will be held in Baltimore again. This is the premier event focusing squarely on the new Unique Device Identification (UDI) regulation promulgated by the U.S. FDA. The final regulation was published during the event last year. The conference is co-produced by the U.S. FDA and it features multiple key FDA officials from the UDI group. I learned a lot at last year’s event and I look forward to learning more this year. RxTrace is a media partner of this conference because I believe it is such a solid event. Early-bird registration ends on September 5th so register soon. You can get an additional $100 off for being an RxTrace reader when you use the discount code “RX” on the registration form. See you there.
Pack Expo, November 2-5, Chicago, IL
I wasn’t able to attend Pack Expo in Las Vegas last year but now that I live in the Chicago area I plan to attend on at least one day, maybe two. Even two days won’t be enough time to cover the whole thing in any kind of detail—it is the largest trade-show I’ve ever attended—but I should be able to hit all the booths in the “Pharma Expo” that is contained within it. Pack Expo alternates each year between Las Vegas and Chicago, with the Chicago event being the larger of the two. With the economy finally showing signs of some vigor, this could be their biggest year yet. I can’t offer you any discount tickets but if you plan to attend and you don’t want to pay the $30 registration fee (before October 4), contact your favorite pharma packaging equipment vendor and ask for a complimentary registration. Odds are, you will get one.
HDMA Traceability Seminar, November 10-12, Arlington, VA
The Healthcare Distribution Management Association (HDMA) holds this seminar every year and it has been my favorite event in the past (see “Terminology: Track and Trace, and Pedigree”). The agenda for this event does not change much from year to year (and neither do the speakers), but it is helpful to attend each year so you can see how attitudes and urgency change in the participants and get the latest regulatory news. This year the event will occur just after the deadlines have past that were established by the “Big-3” wholesale distributors for receiving TS, TH and TS to avoid embargoing. This will be a good opportunity to get your questions answered. The people who attend this event each year include most of the industry veterans of serialization and track and trace deployments. It is a great event to catch up with those people and make new contacts. Hope to see you there.
10th Annual Trade and Channel Strategies Conference, December 10-11, Philadelphia, PA
Here I will be speaking on the same agenda as such luminaries as Dr. Adam Fein, founder of the Drug Channels blog, Pembroke Consulting, and the Drug Channels Institute; and Bill Roth, founding partner of Blue Fin Group. Again, my topic will be the DSCSA and sustainable strategies for meeting it. Register early. Advantage pricing ends October 10. See you there.
And, of course, if the FDA holds any more DSCSA-related meetings, I will also attend those.
I hope to see you all at one of these events this fall. Have I left out your favorite event? Leave a comment and tell us why you like it.