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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.
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.
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.
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.
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.
Check out this webinar from Ben Locwin of Healthcare Sciences Advisors!
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.
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
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.
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.
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
At the 6th Pharmaceutical Traceability Forum, Optel made an exciting industry announcement. Watch the live video here..
- 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
- 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 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.
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.