DSCSA Implementation & Readiness Efforts for 2023

By |2023-03-21T11:13:11-04:0003/20/2023|

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 traceability approaches in November. To allow supply chain stakeholders an opportunity to share their perspectives, the FDA held a 2-day virtual public meeting. DSCSA Implementation [...]

Traps to Avoid When Preparing for Commercial Launch

By |2023-04-17T10:39:49-04:0002/23/2023|

April 6 @ 6-8p Eastern | Boston Marriott Cambridge Traps to Avoid When Preparing for Commercial Launch Preparing for commercial launch is a big deal for most companies. It requires strong leadership and coordination across many functional areas. There are also technical and regulatory hurdles. The company is investing significant efforts and [...]

Commercial Launch Planning on an Accelerated Timeline

By |2024-02-06T10:20:01-05:0002/13/2023|

Commercial Launch Planning on an Accelerated Timeline PDF Version An emerging European biotech company was preparing to commercially launch its first product in the US. The FDA granted the innovative product a priority review given the potential for significant benefit to patients. As a result, the company faced a compressed timeline to [...]

What Commercial Companies Need to Know about S&OP

By |2024-02-06T14:12:14-05:0011/09/2022|

What Commercial Companies Need to Know about S&OP Sales and Operations Planning (S&OP) is an iterative planning process. It ensures cross-functional alignment on sales forecast and performance, as well as manufacturing forecast and performance. It also provides visibility into forecasted demand and an accurate view of volumes for inventory and production. With this [...]

Event Recap: 2022 & Beyond – Serialization Requirements for Manufacturers

By |2022-11-14T11:53:27-05:0010/25/2022|

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 product movement and traceability through the supply chain. The sharing of data is dependent on the Electronic Product Code Information System (EPCIS). Although [...]

Supply Chain Planning for Today’s Uncertain World

By |2023-04-13T14:30:15-04:0009/05/2022|

Webinar on October 19 @ 11a-12p Eastern Supply Chain Planning for Today's Uncertain World Read the Event Recap Supply chain leaders in life sciences companies operate in a highly uncertain environment. Commercial and regulatory uncertainty is now compounded by the risk of supply disruptions and geopolitical barriers. For companies [...]

Event Recap: Building High-Touch Patient Supply Chains

By |2022-11-14T11:51:17-05:0003/18/2022|

Event Recap: Building High-Touch Patient Supply Chains Patient Outcomes: A Shift in Industry Focus The healthcare industry is increasing use of patient outcomes as a measure of quality and value. This drives biopharmaceutical companies to focus on patients in their commercial operations, technical operations, and supply chain. It was first prioritized [...]

Advanced Planning: Developing Supply Risk Mitigation Strategies

By |2024-02-06T10:05:52-05:0002/09/2022|

Advanced Planning: Developing Supply Risk Mitigation Strategies PDF Version Converge conducts a Manufacturing Supplier Risk Assessment and uses the results to build a Supplier Risk Management Plan. A commercial biopharmaceutical company was preparing for their second product launch when senior leadership acknowledged the need to prioritize the supply chain and manufacturing mandates [...]

Implementing a Serialization Program Successfully on the First Try

By |2024-02-06T10:06:36-05:0001/18/2022|

Implementing a Serialization Program Successfully on the First Try PDF Version An emerging specialty biopharmaceutical company was preparing for the U.S. launch of their first drug product. Building out their supply chain would involve implementing a serialization program to meet Drug Supply Chain Security Act (DSCSA) requirements. While Supply Chain team members [...]

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