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.

Join us at GTT NJ!

Learn the latest updates in the industry from professionals and panelists in our COMPLIMENTARY Global Track & Trace Roundtable – East in Ringoes, NJ!


Agenda

  • “One Small Step for Man…”
    • ​Serialization 1.0, 2.0, and 3.0 as relative to the Global Regulatory Landscape
  • “Big 3” Update
    • Serialization & Verification Router Service Plans (HDA)
  • Case Study: Serialization 3.0
    • Enabling a Global Product Authentication Strategy in a Non-Regulated Environment
  • Healthcare Perspective
    • Healthcare systems discuss their Needs and if Supply Chain partners and Solution Providers are listening
  • Manufacturing Roundtable
    • ​Manufacturers discuss compliance readiness, challenges, sustainability, and the next steps
Ringoes, NJ
  • Date: October 9, 2018
  • Time: 1:00-5:00PM (cocktail hour: 5:00-7:00PM)
  • This event is COMPLIMENTARY!
  • Location: The Ridge at Back Brook
    211 Wertsville Road, Ringoes, NJ 08551

Register Now

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On September 19, 2018, the USFDA published a Draft Guidance, Product Identifiers Under the Drug Supply Chain Security Act – Questions and Answers, [Docket Number FDA-2018-D-3175-0002]. This draft guidance introduced some recommendations that were, at the very least, confusing if not confounding to the pharmaceutical supply chain’s strategy, systems, and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

Keep in mind that the FDA is making “recommendations” for interpretation of the DSCSA law, not changes to the law itself. That said, when that document is published as a “final” guidance it will be used by FDA investigators as their guidance for inspection of the various supply chain partners (especially manufacturers and repackagers).

Excellis Health Solutions has performed a detailed analysis of the draft guidance. The attached document represents the comments, questions, and suggestions we will electronically post to the FDA regulations portal (www.regulations.gov).

It is very important that the public (responsible entities within the pharmaceutical supply chain) is active in submitting comments either electronically or written so that the confusion generated by the publication of this draft guidance can be eliminated. Submit your responses to the FDA through one of the following methods:

Excellis Health Solutions remains vigilant to assist the pharmaceutical supply chain design and implement compliant solutions. For additional information visit our website: Excellis Health Solutions

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