Fierce Decentralized Clinical Trials Summit

 September 26-28, 2023   Philadelphia, PA

PREVIOUS TOPICS HAVE INCLUDED:


INTERNAL STAKEHOLDER COLLABORATIONS: CREATE INTER-DEPARTMENTAL EFFICIENCIES TO OPTIMIZE INSPECTION PREPARATION

  • Refine processes that enable internal stakeholders to increase efficiency throughout the entire study, not just during the inspection preparation period
  • Understand nuances of inspection preparation deliverables according to agency expectations
  • Discuss the tools made available through technology to ascertain an accurate status of inspection readiness and facilitate inspection preparation
  • Train and support the education of functional departments to ensure internal synergy
  • Build credulity within your Inspection preparation team

Katherine Taylor, Director, GCP Inspection Management, MERCK

Christina DeLuca, GCP Inspection Lead, Associate Director, MERCK


RECOGNIZE TOOLS TO FOSTER A CULTURE OF COLLABORATION AND INHERENT INSPECTION READINESS

  • Discuss the core components of inspection readiness and how they can be built into everyday processes
  • Understand the importance of your people; how prepared are they to address challenges that come up during inspections?
  • Explain the necessity of interdepartmental collaboration to ensure internal preparedness
  • Communicate the commitment required for change management to be a company-wide initiative that mitigates inspection risk

Lydia Milne, Director, Quality Systems Inspection Program, ASTELLAS

 

BUILD EFFECTIVE TRAINING PROGRAMS FOR THE BIOPHARMA INDUSTRY

  • Define governance model for effective training program
  • Establish tools/LMS needed to manage the training program
  • Explore the competency model and risk-based delivery model
  • Examine various ways to measure training effectiveness

Sharon Brower, Director Training and Process and Continuous Improvements, BRISTOL-MYERS SQUIBB