Event Recap: TraceLink FutureLink Barcelona Conference 2024
TraceLink recently hosted FutureLink Barcelona 2024, their annual European meeting for supply chain participants. Since Europe enacted serialization requirements back…
Perspective
The Evolving Ecosystem for Biopharma Manufacturing
A significant – even seismic – shift is taking place in biopharma manufacturing and technical operations right now. It is…
Perspective
US-China Trade Tension: Increasing Uncertainty for Biopharma
In recent years, the US government has increasingly leveraged trade policy as a tool for broader U.S. foreign policy. This…
Perspective
Highlights from Navigating Serialization Compliance to Meet November’s FDA Enforcement Deadline Webinar
2024 is a crucial year for the life science industry. November marks the end of the DSCSA stabilization period and…
Perspective
Impact of Rejecting Chevron Deference on Biopharma
On June 28, the Supreme Court of the United States (SCOTUS) overruled the most cited legal case in its history, colloquially…
Perspective
Event Recap: FutureLink 2024
At the end of May 2024, TraceLink hosted its annual conference – FutureLink 2024. The event brings together manufacturers, brand…
Perspective
Life After DSCSA Compliance
In September, the FDA provided the pharmaceutical industry with a 12-month extension to the Drug Supply Chain Security Act (DSCSA). The…
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Converge Perspective on the FDA Delayed Enforcement
On June 2, 2023, the Healthcare Distribution Alliance (HDA) submitted to the Federal Drug Administration (FDA) a letter outlining challenges…
Perspective
How Phase 3 Companies Can Better Navigate DSCSA Serialization Requirements
Ulpiano Flores, a business analyst with Converge Consulting, speaks about Phase 3 companies navigating DSCSA serialization requirements in an interview…
Perspective
DSCSA Implementation & Readiness Efforts for 2023
2023 is a crucial year for pharmaceutical trading partners as the Drug Supply Chain Security Act (DSCSA) deadline for full…
Perspective
Event Recap: 2022 & Beyond – Serialization Requirements for Manufacturers
To ensure product safety, the Drug Supply Chain Security Act (DSCSA) requires pharmaceutical trading partners to share data that tracks…
Perspective
Are You Ready for Serialization Implementation?
Serialization implementation is probably on your radar already if you’re an executive at an emerging Biopharma company. Manufacturers need to…
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2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors
Pharmaceutical manufacturers currently share transaction data with their trading partners at the lot level. The Drug Supply Chain Security Act…
Perspective
Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022
Per DSCSA, the U.S. pharmaceutical industry must be exchanging EPCIS data at the serialized package level by November 27,…
Perspective
Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements
While the Drug Supply Chain Security Act (DSCSA) does not require manufacturers to send package-level serialization data downstream until November…
Perspective
Thinking Differently about Safety Stock
Inventory comes in many shapes and sizes, quite literally, but for life sciences one thing is certain: effectively managing inventory…