I’ve been doing a lot of traveling in the last few months since I left Cardinal Health. Right now my wife and I are just finishing up a visit to Culver City, CA where we arrived just in time for the birth of our first grandchild. This was a non-business trip, of course, but all of my other recent travels have been to attend conferences or public meetings of one kind or another.
One of the ways I maximize the return on investment (ROI) of attending conferences is to take lots of notes and then publish internally an analysis of the things that I thought had some important significance to my company. This technique has resulted in a searchable record of my impressions of every speaker and networking contact that struck me for any reason in almost every conference I have attended over the years. I highly recommend that technique for retaining the value offered by each conference and spreading that value around to those in your company who were unable to attend.
What follows is NOT an example of that. Instead, this is a very abbreviated coverage of the conferences and other public events I have attended since starting Dirk Rodgers Consulting, LLC. A true example of proper coverage would include brief highlights of individual speakers and sessions.
California Board of Pharmacy Enforcement Committee meeting, September 11, 2012, San Francisco, CA
During this meeting the committee discussed the progress of the proposed action to recognize the FDA’s Standardized Numeric Identifier (SNI) guidance as complying with the “unique identifier” that is required in California’s pedigree law. The board was to receive public comments on the proposal by September 21 and considering the Board’s schedule, the earliest action isn’t expected until January.
The end of the 45 day period for collecting public comments on Inference was approaching and few of the responses collected to date have the kind of specifics the board will need to support writing actual regulation or rules. The committee heard a number of presentations during the meeting related to Inference and they reiterated their desire for specific details about how companies would expect to use Inference. Members made it clear that they felt that a good regulation regarding the use of Inference is needed but they need more public input to be able to create it.
Presentations or comments were made by several consultants, GS1 US, HDMA (assisted by Cardinal Health), Kaiser Permanente, Axway and Merck.
FDA UDI Conference, September 18-19, 2012, Orlando, FL
Now that the FDA’s proposed rule for Unique Device Identification (UDI) has been published this conference was very informative and very timely. The conference was held in the middle of the public comment period. I wrote three essays about various elements of the proposed rule leading up to this conference (see “FDA Proposed UDI: A Revolution In Number Assignment”, “FDA Proposed UDI: AIDC Requirements”, and “FDA Proposed UDI: The GUDID Database”). The best parts of this conference provided a lot more clarity around all aspects of the current proposal and expected deployment.
The FDA’s Jay Crowley, along with a number of other FDA speakers, provided these details in easy to follow presentations that included excellent Q&A sessions at the end, and all of the FDA speakers were available during breaks to answer one-on-one questions. It was a great value to anyone who will need to implement this future regulation. Missed it? I’ll bet they will repeat it in the spring. Monitor RxTrace for news of the progress of the UDI regulation and implementation of the FDA’s Global Unique Device Identification Database (GUDID)
TraceLink Nexus Conference, September 19, 2012, New Brunswick, NJ
This was a one-day user conference for TraceLink’s line of serialization, ePedigree, Track & Trace and supply network communications solutions. I was recruited to served on a panel discussing global regulatory compliance with serialization and track & trace regulations.
Xavier University Global Outsourcing Conference (GOC), September 24-26, 2012, Cincinnati, OH
This was a very interesting conference that was targeted at Quality and Supply Chain roles of pharma manufacturers—particularly those that make use of contract organizations for R&D, manufacturing, packaging and logistics. The primary emphasis seemed to be on working with contract manufacturers on a global basis while maintaining a high level of quality and meeting regulatory requirements. I was recruited to speak on U.S. supply chain security.
Partnership for Safe Medicines Interchange 2012, September 27, 2012, Washington DC
This was the third Interchange event held by PSM. I’ve attended all three. The event is targeted at global policy-makers and others, and is intended to highlight the problems of counterfeit drugs being sold on the internet and entering our legitimate supply chain. In the past, I have complain about how much time was dedicated to highlighting the problem and how little was dedicated to discussing solutions, but this year there seemed to be more emphasis placed on solutions—particularly national legislation needed to help the FDA fight internet and supply chain crimes.
A number of speakers/panelists were from the Federal agencies involved in fighting these kinds of crimes, including FDA, Department of Justice and Homeland Security, Customs, and Commerce as well as industry and consumer protection groups.
This year there was cause for celebration over the number of high-profile cases that have been successfully prosecuted and the increase in penalties and crime-fighting tools that the federal government has been given with the enactment of the Food and Drug Administration Security and Innovation Act (FDASIA) of 2012.
The highlight of the event was a live speech by FDA Commissioner Margaret Hamburg who discussed the current state of the agency’s fight against counterfeits and other crimes.
The entire event can be viewed on the C-Span website.
GS1 US Healthcare Work Group Forum, October 1-3, Chicago, IL
Interestingly, this event kicked off with a webcast of an interview with FDA Commissioner Margaret Hamburg discussing the new global governance model that is needed to ensure that ingredients and finished pharmaceuticals are manufactured properly and are safe for patients.
There was a very interesting presentation by Abbott Labs, McKesson and the Veterans Administration (VA) about their recent pilot of track and trace data exchange using the Global Healthcare eXchange (GHX) data exchange and checking service prototype. I’ve written about the GHX prototype before (see “Could This Be Your Future ePedigree Exchange Solution?”) and it was very interesting to hear actual users talk about it.
Both Abbott and the VA made use of a light-weight scanning application provided by GHX for generating GS1 Electronic Product Code Information Services (EPCIS) events directly in the GHX repository. Those that Abbott created were pushed into McKesson’s corporate EPCIS so that when the product arrived at their distribution center they could make a local check to confirm that the product received matched what Abbott shipped.
When McKesson shipped the product they created their EPCIS Aggregation and Shipping events in their own EPCIS event repository and then pushed a copy of those events to GHX. Finally, when the VA received the product they used the GHX scanning app to confirm that the serial numbers on the product they received matched those that McKesson shipped and that they were valid serial numbers that Abbott had shipped to McKesson.
I’m hoping to write a more in-depth RxTrace essay about this important pilot soon. I was very impressed and I think you will be too.
LogiPharma 2012 Conference, October 9-11, 2012, Philadelphia, PA
Because of the fast approaching target date of the birth of my grandson I was forced to cut my attendance to only one day of this 2 ½ day event. I was recruited to participate on a panel called, “Trading Partners For Track & Trace Readiness On Data Sharing, ERP And Operational Issues To Create More Visibility In Supply Chains”
At all of these events I met people who are RxTrace readers. It is always very encouraging to meet people who have found value in my writing. Here is a list of events that I currently plan to attend through the end of 2012. If you are also attending one of these events, please find me and introduce yourself. If you’d like to arrange a meeting while we are there together, let me know in advance.
Pharmalot Webinar, “Re-orienting Your Business To Comply With Serialization and ePedigree Regulations”, October 24, Noon ET. Click on the link for more information and to register.
Pack Expo, Chicago, IL, October 28-31. I currently plan to attend for at least one of the days, maybe two.
Reconnaissance International’s 7th Global Forum on Pharmaceutical Anti-Counterfeiting and Diversion, Washington DC, November 27-29.
California Board of Pharmacy, Enforcement Committee meeting, December 4, location TBA.
8th Annual Trade and Channel Strategies, Philadelphia, PA, December 5-6. I’ve been recruited to speak about global track and trace regulations.
One event that I normally wouldn’t miss is the HDMA Track and Trace Technology Seminar, but this year it is being held during a week that I am busy so I won’t be able to attend. I must admit that last year it was getting a little repetitive with the same speakers talking about the same topics as previous years, but I guess it is billed as a “seminar” rather than as a “conference” so I guess that should be expected.
I hope to see you at one of these events.