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Expert Insight into Top Pharmaceutical Challenges Surrounding Serialization: Aggregation and CMO Integration

Expert Insight into Top Pharmaceutical Challenges Surrounding Serialization: Aggregation and CMO Integration

In anticipation of the Pharmaceutical Traceability Forum, we spoke with Matt Sample and Christopher Howell about the top pharmaceutical challenges surrounding Serialization: Aggregation and CMO Integration. Both speakers shared their unique perspectives on the topic and also expressed what they were most excited to learn about at the upcoming event. 

Preparing for 2023: Advice from a Top Wholesaler

Preparing for 2023: Advice from a Top Wholesaler

In advance of the Forum, we spoke with an elite representative from the wholesaler side of pharmaceutical shipping about the plans his company has and the challenges he’s facing. Take these into consideration today for best results 7 years from now.

Tools of the Trace

Tools of the Trace

Past speaker Peter Sturtevant, Sr. Director of Industry Engagement at GS1 US, discusses the tools which will help you achieve and surpass DSCSA compliance, such as the Electronic Product Code Information Service and the Master Data Exchange. 

The Hidden Requirements of Enterprise Serialization Systems

The Hidden Requirements of Enterprise Serialization Systems

Past speaker Scott Pugh, Principal at Jennason, talks about the key functionality, architecture, hosting, and deployment, implementation and validation of enterprise serialization systems in this past presentation.

Serialization: Driving Business Value Beyond Compliance

Serialization: Driving Business Value Beyond Compliance

As serialization and track-and-trace capabilities go mainstream to meet regulatory compliance mandates, pharmaceuticals companies should simultaneously explore how these tools and techniques can improve supply chain planning and operations, elevate patient and doctor engagement, and increase sales and marketing effectiveness. Whitepaper courtesy of Cognizant.

Serialisation Case Studies: SMEs and CMOs

Serialisation Case Studies: SMEs and CMOs

Pharma IQ spoke with Mark Davison, Chief Executive Officer at Blue Sphere Health Ltd, and Vetter Pharma to gain insight into SME pharma & biotechs for serialization, as well as strategies that CMOs can implement to succeed in serialization.
Pharmaceutical Traceability Industry Experts EBook

Pharmaceutical Traceability Industry Experts EBook

Before you hear from these great speakers at the Forum, read their thoughts on serialization within the life sciences industry. We sat down with speakers from top companies such as AmerisourceBergen, Merck & Co., NC Mutual Wholesale Drug Company and Neurocrine Biosciences, find out what they had to say!
Examining Serialization as a 21st Century Approach to Anti-Counterfeiting

Examining Serialization as a 21st Century Approach to Anti-Counterfeiting

Check out this webinar from Ben Locwin of Healthcare Sciences Advisors! 

Achieving Scannable GS1 Codes for DSCSA Compliance

Achieving Scannable GS1 Codes for DSCSA Compliance

Take a look at this exclusive whitepaper put together by VideoJet. Within the paper you will find out more about how the DQSA and DSCSA compliance regulations can impact your overall operation.

Pharmaceutical Serialization and Traceability 2017 Trend Report

Pharmaceutical Serialization and Traceability 2017 Trend Report

With time running low, Pharma Logistics IQ tracks the state of the industry’s serialization projects. This year’s research report maps out and measures the changes in consensus as the industry advances closer to an entirely track-and-trace pharmaceutical environment. Sections covered:

  • Project Planning
  • Implementation Progress
  • Traceability In Operation 
  • Benefits Beyond Compliance
Serialization: An Implementation Guide

Serialization: An Implementation Guide

This white paper gives in-depth descriptions of the:

  • Challenges driving new serialization regulation.
  • Pending regulation requirements and deadlines.
  • Implementation and interoperability challenges in serialization solutions.
  • New holistic serialization solution from Rockwell Automation built on a modular and scalable off-the-shelf control and information platform.
  • Business benefits of the common data source created by serialization.

Working with CMOs: Serialization Tends to Fail in the Details

Working with CMOs: Serialization Tends to Fail in the Details

This is the second article in a series looking at how to avoid the supply risk when working with CMOs on serialization. In this article I will discuss another six learnings covering everything from resource-planning to clarifying your RACI.
Implementing a Serialization Project Post DSCSA

Implementing a Serialization Project Post DSCSA

Are you ready? The likely answer is no, but it’s just as likely that you are working on it. The fact is, the pharmaceutical industry is still wrestling with challenges which will continue to evolve as serialization systems are rolled out.

7 Steps To Implementing A Serialization Project

7 Steps To Implementing A Serialization Project

Take sneek peak at the 7 steps to implementing a full serialization project:

1: Get ready for a cultural change.

2: Invest in high volume items

Optel Acquires Verify Brand to Set the Stage for End-to-End Traceability

Optel Acquires Verify Brand to Set the Stage for End-to-End Traceability

At the 6th Pharmaceutical Traceability Forum, Optel made an exciting industry announcement. Watch the live video here..

youtube optel

Electronic Product Code Information Services (EPCIS) “Push” Method

Electronic Product Code Information Services (EPCIS) “Push” Method

2017 Presentation!

  • Distributed databases
  • Sending EPCIS data (TI,TS) to forward trading partners.
  • One-up, One-down visibility

Presentation by Peter Sturtevant Senior Director Industry Development, Pharmaceuticals GS1 US

Understanding Blockchain and DSCSA

Understanding Blockchain and DSCSA

2017 Presentations!

  • Ensures your data requestors are legitimate with minimal effort
  • Does not require a central repository
  • Works seamlessly with GS1 EPCIS

Presentation by Robert Celeste, Founder, Center for Supply Chain Studies

The Final Stages of Serialization

The Final Stages of Serialization

Pharma IQ conducted extensive market research to pinpoint the concerns and priorities of those in the more mature phases of serialization.
Software Best Practises: Implementation & Data Integration

Software Best Practises: Implementation & Data Integration

Effective data management is imperative to achieve regulatory compliance with a serialisation programme. Non-standard data exchange and integration methods are seen as one of the biggest hurdles in serialisation compliance. In light of the data responsibilities expected within serialisation projects, Pharma IQ consults with a selection of experts on software best practices - data integration and implementation.
Top 10 Pharma and Biotech Trends to Watch in 2018

Top 10 Pharma and Biotech Trends to Watch in 2018

Pharma IQ takes a look at some of the trends forecasted to take hold this year: disruption for vendor landscapes, regulatory intervention and sophisticated analytics technologies gaining speed.
Traceability in Operation Market Research: Concerns and Priorities

Traceability in Operation Market Research: Concerns and Priorities

Pharma IQ collected the following market research to pinpoint the concerns and priorities of those in the more mature phases of serialization. Commentary supplied by Pasi Kemppainen, Executive Consultant, Pharma Serialization and Traceability.
Drug Supply Chain Security Act (DSCSA) Interactive Implementation Timeline

Drug Supply Chain Security Act (DSCSA) Interactive Implementation Timeline

The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

To help ensure you meet the November, 23, 2023 deadline, we created this  interactive presentation that sheds light on the upcoming deadlines, requirements and other need-to-know information.

Implementing Serialization in the Drug Supply Chain

Implementing Serialization in the Drug Supply Chain

Currently, the pharmaceutical industry uses tracking and tracing technology heavily in the upstream supply chain. Maintaining visibility of the source of Active Pharmaceutical Ingredients (API) is of utmost importance.

Editor’s Note: Every year, 40 or so students in the MIT Center for Transportation & Logistics’ (MIT CTL) Master of Supply Chain Management (SCM) program complete one-year thesis research projects. The students are early-career business professionals from multiple countries with 2 to 10 years of experience in the industry. Most of the research projects are chosen, sponsored by, and carried out in collaboration with multinational corporations. Joint teams that include MIT SCM students and MIT CTL faculty work on the real-world problems. In this series, we summarize a selection of the latest SCM research. The SCM thesis Serialization of Prescription Drugs in the US: A Centralized View was authored by Aisha Nabiyeva and David Z. Y. Wu, and supervised by Dr. Bruce Arntzen, Executive Director, Supply Chain Management Program, MIT Center for Transportation & Logistics.