Archives: Agenda
Streamlining Success: An Integrated Approach to Clinical Quality Assurance in Supply Chains
| · Regularly auditing suppliers and manufacturing partners to ensure compliance with regulatory standards
· Conducting regular training and workshops to align all parties on quality assurance standards and practices · Developing and maintaining detailed risk management plans |
Enhancing Drug Forecasting to Reduce Waste and Optimize Supply Chains
• Challenges in Clinical Drug Supply Management
• New Technologies in Clinical Drug Supply Management
• Global Case Studies & Best Practices
Optimizing Central Lab Supply Chains: Overcoming Logistical Barriers in Clinical Sample Management
| · Addressing challenges in collection, labeling, packaging, and international shipping
· Ensuring cold chain integrity to maintain sample viability and data accuracy · Navigating cross-border requirements, permits, and documentation delays |
Lunch and networking
GMP and Global Trials: Managing Multi-Regional Requirements for Manufacturing
- Understanding Data Integrity (DI) for Effective GMP Management in CMO/CDMO
- A Trend of Parametric Release Criteria for Aseptic Drug Production by MFDS (Korean Food and Drug Administration)
Advancing Adaptive Strategies for Clinical Trial Supply Manufacturing
| · Strategies for just-in-time manufacturing to reduce inventory and waste
· CMO Selection: Aligning Partner Capabilities with Evolving Clinical Supply Demands · Modernizing the Supply Chain: Evaluating and Adopting Next-Generation Manufacturing Solutions |
Localising clinical trial supply in (J)APAC: Risk, resilience, and revenue
With JAPAC now the fastest-growing clinical trial region, sponsors need local supply strategies to de-risk programs and improve patient access. This session explains the necessity of building resilient, compliant local supply networks and the commercial upside for manufacturers and CROs across and within JAPAC
- Why JAPAC matters now: JAPAC trial activity is accelerating vs. other regions, major growth in China and parts of Asia(https://www.reuters.com/business/healthcare-pharmaceuticals/china-pharma-firms-turn-local-reagent-s…)
- Supply risk: reliance on Europe/US creates delays and vulnerability: Local sourcing reduces lead times and tariff risk (recent moves to local reagents/manufacturing)(Reuters)
- Practical actions: rapid tech-enabled cold chain, local comparator sourcing, in-region labelling/regulatory templates and contract manufacturing partnerships
Morning refreshments and networking
Building Resilient Clinical Supply Chains: From Seamless Comparator Sourcing, Labeling, Packaging to Last-Leg Delivery in Global Clinical Trials
This session, will provide an insightful overview of how Jupiter Research Services’ bespoke service model enables Sponsors, CROs, and CDMOs to leverage a truly global and resilient clinical supply chain – encompassing Seamless Comparator Sourcing, Regulatory-Compliant Labeling & Packaging, and Efficient Last-Leg Delivery across multi-regional clinical trials
- Identifying, Mapping & Mitigating Risks in a Volatile Supply Chain
– Understanding how global shortages, parallel trade shifts, customs complexities, and cold-chain vulnerabilities impact study timelines—and how to proactively mitigate them. - Resilient & “Glocal” Comparator Sourcing Strategies
– Approaches that combine global reach with local execution to reduce bottlenecks, prevent study interruptions, and secure critical US/EU comparator products for global trials. - Overcoming Regulatory Challenges for Uninterrupted Study Operations
– Navigating FDA, EMA, MHRA, MFDS, PMDA, CDSCO, DSCSA/EPCIS, and QP release requirements to maintain continuity and compliance across regions. - Integrated Labeling, Packaging & Blinding for OTD (On-Time Delivery)
– A coordinated, risk-based approach to labeling, packaging, kitting, and blinding that ensures accuracy, compliance, version control, and timely delivery. - Application of JIT, DTP & Innovative Supply Models
– Deploying Just-in-Time (JIT) packaging, Direct-to-Patient (DTP) distribution, and flexible logistics models that support decentralized and hybrid trials. - Case Studies: Successful End-to-End Execution
– Real-world examples demonstrating rapid comparator procurement, seamless global-to-local execution, proactive QA oversight, and uninterrupted delivery to sites and patients.