There is a rare alignment of events that will happen in the first week of December that is so special that you need to put it on your calendar. There are two important pharma serialization events that will occur in the Washington DC area and anyone with a serious interest in that subject should attend both. These events line up perfectly to allow you to travel once, and spend four days that will solidify your understanding of the issues and opportunities embedded within the Drug Supply Chain Security Act (DSCSA) in particular, and pharma serialization in general.
DON’T-MISS EVENT #1
First is the two-day FDA DSCSA Public Meeting in Silver Spring, MD on December 5-6. This event is the second of three the FDA has scheduled to investigate ideas for meeting the special requirements due to kick in on November 27, 2023 (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”). This is the so-called “Enhanced Drug Distribution Security” (EDDS) phase—the final phase of the DSCSA.
In the EDDS, all trading partners will be required to operate their part of the supply chain using the full DSCSA unique identifier, including the Standardized Numerical Identifier (SNI). This requires the operation of that nebulous, “interoperable, electronic system” that must be used by all trading partners to maintain traceability data. This series of public meetings by the FDA are designed to help them, and the industry eventually come to some conclusions about what that “system” will be and how it will operate. (For my report on the first in this series of meetings, see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”.)
This is the only one of the three that will last for two days. This time the topics of discussion will be:
- Electronic interoperability
- Standards for data exchange
- Data architecture
- Aggregation and inference
All of these topics are fully loaded with passionate beliefs on all sides, and any one of them are capable of consuming the full two days. The FDA won’t let that happen, but if you only make it to one of the three FDA DSCSA Public Meetings, this is the one.
For registration information, see this FDA webpage.
DON’T-MISS EVENT #2
The second don’t-miss event will occur a few Metro stops away in Washington DC on December 7-8—the two days that immediately follow the FDA Public Meeting. This is IQPC’s Pharmaceutical Traceability Forum | Interactive event. This event promises to continue the passion-filled conversations that the FDA starts, but without the constraints placed on the participants. Let’s take a close look at the agenda.
The two-day agenda is packed with presentations by industry veterans from all segments of the pharma supply chain, speaking on topics that have a heavy emphasis on the bottlenecks to compliance and the design and operation of the EDDS in 2023. Day one opens with an important recap of the discussions on pressing DSCSA updates coming out of the FDA Public Meetings from the days before and the one in August. Presented by experts who can explain the meaning and implications of those meetings. Even the FDA ought to attend that session, if not the whole event.
The very next session is dubbed, “The Great Debate – Aggregation: Candidly Reviewing the Pros and Cons of Building Aggregation into your Processes”. This is a panel discussion that pits Kevan MacKenzie, Director of Serialization Technology, McKesson against Dave Mason, Global Program Serialization Lead, Sandoz/Novartis. Sparks are going to fly, but more importantly, we will all learn what makes this such a fiery topic—and why it is such an important one to the future of the industry. This one alone is worth the price of admission!
The next session is called “Bottleneck Breakouts” covering the challenges everyone will have sooner or later, including grandfathering, resource challenges and different software versions between trading partners.
From this point on it just gets better. Topics like reverse chargeback tracking, the HDA’s Verification Router Service, maintaining data integrity and accuracy in a post-serialization supply chain, CFR Part 11, outsmarting counterfeiters through serialization and increased vigilance—and that’s all just Day One.
Day Two of the agenda includes discussions on the EU Falsified Medicines Directive, updates on pharma serialization and tracing regulations from around the world, the operational complexities brought on by serialization, and a discussion of some of the technologies that might comprise the EDDS. Those technologies include Blockchain, a centralized database, a “push” method and/or a router service. You will gain insight into what each of these could mean to your business if they are selected. And More!
If you are going to the Washington DC area for one of these two events, you owe it to your company, your team and yourself to sign up for the other one. With your travel costs already covered, it’s almost like getting two important events for the cost of one. You will return with a fresh perspective on the challenges and the opportunities serialization will bring to you and your company. Don’t miss it. This kind of nexus of events does not occur very often.
To register for Pharmaceutical Traceability Forum | Interactive, go to http://www.pharmaceuticaltraceabilityforum.com/.