Archives: Agenda

• Understanding FDA regulations and guidelines for ensuring quality and integrity
• Implementing GMP standards to maintain consistency and reliability in production and distribution of trial materials
• Adopting a risk-based approach to quality management
• Establishing robust supplier qualification processes to select reliable partners and ensure adherence to quality standards

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the clinical supply chain industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable will last for 45 minutes, after which delegates will be given the opportunity to swap to a different roundtable.

ROUNDTABLE 1: Topic TBC
Carmin Cerullo, Agriculture Operations Manager, San Francisco and Portland Field Office, U.S. Customs and Border Protection
Jolien Wychules, Biological Threat Operations Specialist, San Francisco and Portland Field Office, U.S. Customs and Border Protection

ROUNDTABLE 2: Topic TBC
Luiz Barberini, Head of External Manufacturing, Latin America, Bayer

ROUNDTABLE 3: Data, analytics and GenAI in clinical supply chains

• Interacting earlier for supply to give input and gain information sooner so they can assist and be prepared
• Establishing clinical team needs: what, when and where
• Building and maintaining strong relationships between teams

Support teams are often seen as reactive problem-solvers—but what happens when they’re embedded early in the trial lifecycle? This session explores how technical support can play a proactive role in study success. We’ll discuss how early involvement in processes like the Study Maintenance Plan and Go-Live allows support teams to anticipate challenges, prepare sponsors and sites, and respond more effectively when issues arise. Join us for a practical conversation on how collaboration and foresight can make support a strategic asset in clinical trial delivery.

• Evaluating sourcing, shelf-life and regulatory constraints for high risk items
• Mapping global supply chain dependencies and transit vulnerabilities
• Implementing strategies to mitigate against supply chain risk
• Collaborating cross-functionally to align risk assessment with trial timelines and priorities