Global Track & Trace (GTT) was created in 2009 to support the Pharmaceutical Industry as it relates to the product serialization mandates affecting the constituents in the Pharmaceutical Supply Chain.

The GTT mission from inception was to foster global collaboration between the pharmaceutical supply chain partners to help educate and understand the impact of the Regulatory Mandates they face, while at the same time identifying business value and Change Impact for our members.

As part of this effort, GTT monitors global regulatory mandates, reports those updates to our members via the ‘Regulatory Update’ tab. We research the local market Ministries of Health teams, review the GS1 standards and make this data available to the GTT members to support their international compliance projects. Finally, GTT hosts bi-annual consortium meetings with industry participants to discuss and collaborate on ways companies affected by these regulations can meet the requirements.

Events

Our latest Global Track & Trace (GTT) events are here! Join us in San Diego, CASouth San Francisco, CA; and Moscow, Russia!
 

San Diego, CA
  • Date: June 11, 2019
  • Time: 1:00-5:00PM (cocktail hour: 5:00-7:00PM)
  • Location: San Diego Marriott Del Mar (11966 El Camino Real, San Diego, CA 92130
  • Topics:
    • Best Practices Lessons Learned: Peer presentations on their serialization journey from strategy through sustainability, including future requirements and value initiatives–what did they do, when, how, why, and what would they do different?
    • Commercialization Readiness: key considerations and “safe bets” for clinical companies preparing to launch while building their back-office infrastructure and enterprise systems at the same time
    • Saleable Returns / Verification Router Service (VRS): what is it and do you need one?
    • Going to the EU: how to build on your DSCSA foundation while navigating EMVO/NMVO systems, resulting alerts, and other challenges, such as specialized distribution?
    • Quality’s Intersection with Serialization: how and when do Quality systems and processes converse with Serialization? Best practices conversation on how to build a serialization-ready Quality program that secures and accelerates your product launch.
    • Regulatory Update: EU aggregation, other emerging/global markets, and industry working group updates (HDA, PDSA, GS1) on DSCSA Saleable Returns and 2023 interoperability

Register Now!

South San Francisco, CA
  • Date: June 12, 2019
  • Time: 1:00-5:00PM (cocktail hour: 5:00-7:00PM)
  • Location: Embassy Suites by Hilton San Francisco Airport Hotel (250 Gateway Blvd., South San Francisco, CA 94080)
  • Topics:
    • Best Practices Lessons Learned: Peer presentations on their serialization journey from strategy through sustainability, including future requirements and value initiatives–what did they do, when, how, why, and what would they do different?
    • Commercialization Readiness: key considerations and “safe bets” for clinical companies preparing to launch while building their back-office infrastructure and enterprise systems at the same time
    • Saleable Returns / Verification Router Service (VRS): what is it and do you need one?
    • Going to the EU: how to build on your DSCSA foundation while navigating EMVO/NMVO systems, resulting alerts, and other challenges, such as specialized distribution?
    • Quality’s Intersection with Serialization: how and when do Quality systems and processes converse with Serialization? Best practices conversation on how to build a serialization-ready Quality program that secures and accelerates your product launch.
    • Regulatory Update: EU aggregation, other emerging/global markets, and industry working group updates (HDA, PDSA, GS1) on DSCSA Saleable Returns and 2023 interoperability

Register Now!

Moscow, Russia
The Russian pharmaceutical traceability requirements present a challenge like no other, but our industry-leading experts will help.
Meet the experts at Global Track and Trace (GTT) Russia to talk traceability, your challenges, best practice in Moscow. We will have the practical tips that will start your serialization program off right and keep it on the right track.

  • Dates: June 24-26, 2019
  • Location: Ararat Park Hyatt Moscow
  • Agenda:
    • 24 June: Welcome reception, cocktails, and dinner
    • 25 June: Meet the experts through a series of Q&As, panel, and roundtable discussions focusing on the CRPT, supply chain processes, and regulatory compliance
    • 26 June: Santens 3PL site visit

Register Now!

News

DSCSA Compliance: Industry is still in the trenches

Nov. 27, 2018, was to be a red-letter day in the 10-year program to implement an end-to-end pharma traceability system. Did industry meet the deadline?

“This is shaping up like Y2K did back in 2000,” says Greg Cathcart, CEO of Excellis Health Solutions. “A lot of work has been done; a lot of work is yet to do, and because of the grandfathering of unserialized product, it will be months or years until we’re where we need to be.”

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FDA Guidance for DSCSA released!

On September 19, 2018, the USFDA published a Draft Guidance, Product Identifiers Under the Drug Supply Chain Security Act – Questions and Answers, [Docket Number FDA-2018-D-3175-0002]. This draft guidance introduced some recommendations that were, at the very least, confusing if not confounding to the pharmaceutical supply chain’s strategy, systems, and validated processes that have been widely adapted for compliance to the DSCSA regulation.

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