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DIA Pharmacovigilance and Risk Management Strategies Meeting. FDA Requires Unique Device Identification Intagras Blog. SPL grapic on FDA utilization. DIA Pharmacovigilance and Risk Management Strategies Meeting. I attended the DIA Pharmacovigilance and Risk Management Strategies meeting this week in Washington, DC. The meeting’s focus was a combination of risk management planning, drug safety, novel data mining methods for signals and evidence including social media and emerging markets. Rob Leonetti, VP.

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Blog Intagras | Just another WordPress site | blog.intagras.com Reviews

https://blog.intagras.com

DIA Pharmacovigilance and Risk Management Strategies Meeting. FDA Requires Unique Device Identification Intagras Blog. SPL grapic on FDA utilization. DIA Pharmacovigilance and Risk Management Strategies Meeting. I attended the DIA Pharmacovigilance and Risk Management Strategies meeting this week in Washington, DC. The meeting’s focus was a combination of risk management planning, drug safety, novel data mining methods for signals and evidence including social media and emerging markets. Rob Leonetti, VP.

INTERNAL PAGES

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1

SPL grapic on FDA utilization | Blog Intagras

http://blog.intagras.com/spl-grapic-on-fda-utilization

DIA Pharmacovigilance and Risk Management Strategies Meeting. FDA Requires Unique Device Identification Intagras Blog. SPL grapic on FDA utilization. SPL grapic on FDA utilization. Here is an e-mail that was sent out by Lonnie Smith of the FDA. The e-mail provides a link that has a graphic of how three different Federal government agencies may utilize a single product SPL file for different purposes. Begin E-mail from FDA * * *. This entry was posted in Electronic Labeling. August 26, 2013.

2

admin | Blog Intagras

http://blog.intagras.com/author/admin

DIA Pharmacovigilance and Risk Management Strategies Meeting. FDA Requires Unique Device Identification Intagras Blog. SPL grapic on FDA utilization. DIA Pharmacovigilance and Risk Management Strategies Meeting. I attended the DIA Pharmacovigilance and Risk Management Strategies meeting this week in Washington, DC. The meeting’s focus was a combination of risk management planning, drug safety, novel data mining methods for signals and evidence including social media and emerging markets. Rob Leonetti, VP.

3

Global Unique Device Identification Database | Blog Intagras

http://blog.intagras.com/tag/global-unique-device-identification-database

Tag Archives: Global Unique Device Identification Database. FDA Requires Unique Device Identification Intagras Blog. On Tuesday, September 24th 2013, the Department of Health and Human Services (HHS) published the following in the Federal Register Volume 78, Number 185, Part V, requiring a Medical Device Unique Device Identification System. Link to the Federal Register Volume 78, Number 185, Part V: http:/ www.gpo.gov/fdsys/pkg/FR-2013-09-24/pdf/2013-23059.pdf. This entry was posted in UDI.

4

Interesting Article | Blog Intagras

http://blog.intagras.com/interesting-article

DIA Pharmacovigilance and Risk Management Strategies Meeting. FDA Requires Unique Device Identification Intagras Blog. SPL grapic on FDA utilization. It is exciting to see that the FDA is continuing to expand electronic labeling! Full report (25 pages). Http:/ www.gao.gov/assets/660/655760.pdf. Http:/ www.gao.gov/assets/660/655761.pdf. This entry was posted in Electronic Labeling. July 10, 2013. SPL grapic on FDA utilization →. Leave a Reply Cancel reply. You must be logged in. To post a comment.

5

Global Labeling Tracking | Blog Intagras

http://blog.intagras.com/category/global-labeling-tracking

DIA Pharmacovigilance and Risk Management Strategies Meeting. FDA Requires Unique Device Identification Intagras Blog. SPL grapic on FDA utilization. Category Archives: Global Labeling Tracking. DIA Pharmacovigilance and Risk Management Strategies Meeting. Http:/ www.diahome.org/Tools/Content.aspx? Is your organization as prepared for efficient labeling updates as it could be? Http:/ www.intagras.com. Rob Leonetti, VP. This entry was posted in Global Labeling Tracking. January 20, 2014.

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Updated Guidance for Naming of Drug Products Containing Salt Drug Substances

http://www.intagras.com/news-and-events/updated-guidance-for-naming-of-drug-products-containing-salt-drug-substances.aspx

2016 GDT and RMT Product Advisory Board Meeting. GDT Version 5.0 Is Now Available. Updated Guidance for Naming of Drug Products Containing Salt Drug Substances. Intagras to Present and Sponsor at the 3rd Annual Pharma Labeling Compliance conference. Intagras to Present and Sponsor at 7th Pharma Packaging and Labeling USA conference (PHPL). Intagras to attend the GPhA 2014 Annual Meeting Exposition at the JW Marriott Grand Lakes, Orlando Florida, February 19-21. The XEVMPD maintenance guidance published.

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Intagras to Present and Sponsor at the 3rd Annual Pharma Labeling Compliance conference

http://www.intagras.com/news-and-events/intagras-to-present-and-sponsor-at-the-3rd-annual-pharma-labeling-compliance-conference.aspx

2016 GDT and RMT Product Advisory Board Meeting. GDT Version 5.0 Is Now Available. Updated Guidance for Naming of Drug Products Containing Salt Drug Substances. Intagras to Present and Sponsor at the 3rd Annual Pharma Labeling Compliance conference. Intagras to Present and Sponsor at 7th Pharma Packaging and Labeling USA conference (PHPL). Intagras to attend the GPhA 2014 Annual Meeting Exposition at the JW Marriott Grand Lakes, Orlando Florida, February 19-21. The XEVMPD maintenance guidance published.

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Regulatory Compliance Software | Intagras

http://www.intagras.com/default.aspx

Intagras specializes in making the regulatory process manageable as well as intuitive for life sciences, pharmaceutical and other companies marketing medicines and more. Tracing all the updates for all affiliates is both time consuming and costly, and frequently complicated by inaccurate methods of updating and tracking. Discover more about the robust suite of powerful, fully configurable structured authoring solutions offered by Intagras. Pharmaceutical and Medical Device compliance functionality for FD...

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ESM Portal for EMA Product Submission Management | Intagras

http://www.intagras.com/our-products/esm-portal.aspx

ESM Portal Data Sheet. Provides functionality for pharmaceutical companies that market products in the EEU to comply with the European Medicines Agency (EMA) requirement for submission of information on Medicines by marketing-authorization, holders. For more information, or to schedule a demonstration, call Intagras at (813) 226-1863. Website development by Bayshore Solutions.

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Global implementation tracking for your Pharmaceutical Business | Intagras

http://www.intagras.com/our-products/gdt-portal.aspx

GDT Portal Data Sheet. Ldquo;Intagras is a great company to work with, they strive to always listen and understand your particular needs. They stay abreast to the changes in the regulatory world and are innovative in their solutions.”. Director Strategic Global Labeling, Baxter Healthcare. Global Decision Tracking (GDT) Portal is a web-based application that provides global pharmaceutical corporations with complete transparency into their labeling implementation process., GDT Portal provides decision...

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Product Submissions & FDA Submissions | Intagras

http://www.intagras.com/our-services.aspx

Our services and our people. Managing product labeling within the pharmaceutical industry is a complex task made even more difficult by the necessity of maintaining compliance with health authority requirements, depending on the global reach of your organization. Since 2005, pharmaceutical regulatory agencies have continued to expand electronic submission requirements. Current draft guidance continues to show that pharmaceutical regulatory agencies will only continue to expand and leverage the ca...

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Customer Service

http://www.intagras.com/support/customer-service.aspx

Intagras believes that excellent customer service is the essential follow-on from excellent products. We are never satisfied until we know that you are satisfied. That is the basis of everything we undertake on your behalf. Customer Service can be reached at the following numbers:. You may also reach Customer Service via email by filling out the form below:. Website development by Bayshore Solutions.

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Sales Department

http://www.intagras.com/support/sales-department.aspx

We want to hear from you. We appreciate your interest in our products and services. We believe that our applications are best in class and can benefit your organization in a number of ways. Our focus is always on ensuring that your workflow is streamlined, as well as bringing increased efficiencies and effectiveness to your SPL efforts. Let us show you how by scheduling a live demonstration of any of our products. Sales can be reached at the following numbers:. GDT Portal (Global Decision Tracking).

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Pharma Labeling Software Support| Intagras

http://www.intagras.com/support.aspx

To this end, our Intagras software support representatives undergo rigorous training aimed at ensuring a clear and comprehensive understanding of our customers’ industries, as well as a familiarity with the common issues they experience. From there, they are trained in a systematic approach to problem definition and resolution that emphasizes permanent fixes, not band-aid solutions. The goal is to keep you moving forward, no matter what may occur. Website development by Bayshore Solutions.

intagras.com intagras.com

News and Events

http://www.intagras.com/news-and-events.aspx

2016 GDT and RMT Product Advisory Board Meeting. GDT Version 5.0 Is Now Available. Updated Guidance for Naming of Drug Products Containing Salt Drug Substances. Intagras to Present and Sponsor at the 3rd Annual Pharma Labeling Compliance conference. Intagras to Present and Sponsor at 7th Pharma Packaging and Labeling USA conference (PHPL). Intagras to attend the GPhA 2014 Annual Meeting Exposition at the JW Marriott Grand Lakes, Orlando Florida, February 19-21. The XEVMPD maintenance guidance published.

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DIA Pharmacovigilance and Risk Management Strategies Meeting. FDA Requires Unique Device Identification Intagras Blog. SPL grapic on FDA utilization. DIA Pharmacovigilance and Risk Management Strategies Meeting. I attended the DIA Pharmacovigilance and Risk Management Strategies meeting this week in Washington, DC. The meeting’s focus was a combination of risk management planning, drug safety, novel data mining methods for signals and evidence including social media and emerging markets. Rob Leonetti, VP.

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