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 next Global Track & Trace (GTT) Dispenser Roundtable is on May 12, 2020!

2020 is the Year of Compliance – Are you ready?

This is your exclusive invitation to get to the heart of the Drug Supply Chain Security Act (DSCSA) from the “dispenser’s” point of view. With the upcoming 2020 serialization deadline and many organizations not being fully compliant with current DSCSA requirements, it is now more important than ever to understand what retail pharmacy and healthcare organizations need to “check the box”.

Compliance alone will change your current processes, supplier relationships, and technologies. With a strong compliance foundation, you have the opportunity to control that change and build on top of it (if you choose) to create quantifiable and meaningful value.

In its third year, the expanded roundtable is an opportunity for healthcare & retail pharmacy leaders to meet and discuss DSCSA in a small group setting designed to promote interaction and generate tangible takeaways for your organization.

Information
Date: Tuesday, May 12, 2020
Time: TBA
Location: New Jersey (location TBA)

This is a complimentary event.

Agenda TBA.

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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