Hot Topics in Clinical Supplies
Track:
Clinical Operations
Day & Time:
June 27, 9:00AM - 10:30AM
Session Number:
401
Room Number:
103
Level:
Intermediate
Type:
Symposium
Title:
Hot Topics in Clinical Supplies
Chair(s):
Chuck Harris
Director, Product Development
Endpoint Clinical, Inc., United States
Description:
This symposium will address a number of current clinical supplies topics, including managing the ever-growing costly needs of large-scale investigator-initiated studies (IIS)/investigator-initiated trials (IIT)/investigator-sponsored trials (IST) program management, mitigating risk in your interactive response technology (IRT) system’s automated supply chain configuration, and an update on methods for maintaining regulatory compliance with continuously evolving import/export processes. Through a combination of instruction and case studies, our panel will surface recent developments in these areas that impact a broad spectrum of clinical operations stakeholders.
Learning Objective(s):
Explain clinical supplies pooling as it pertains to managing IIS/IIT/IST using Interactive Response Technology (IRT); Assess how IRT supply parameter settings impact the overall study supply chain, and assessing which supply parameters should be managed manually versus automatically; Describe the main elements of compliant and safe import management for clinical supplies, including Good Import Practice, and approaches for successful import/export management.
Presentation(s) & Speaker(s):
Supply Pooling: Lessons Learned for Making It Work in Your IIS/IIT Trials
Chuck Harris
Director, Product Development
Endpoint Clinical, Inc., United States
Managing Drug Supply via an Interactive Response Technology (IRT) System
Karen McNamara, MBA
Senior Manager, Clinical Supply
Infinity Pharmaceuticals, Inc., United States
Enhancing the Security and Regulatory Compliance of Investigational Drug and Study Material Supply to International Sites
Andrey Gurachevsky
Senior Technical Logistics Coordinator
PAREXEL International, Germany