Event Schedule
  • Define end-to-end process and controls using quality by design and risk-based principles
  • From business case to technical solutions and roadmap, identify key steps and components
  • Define TMF operational model, roles and ensure user engagement
  • Effective revision of your process documents
  • Certify that the SOPs and WIs align
  • Create efficient TMF reference model templates
  • Apply real-time KPIs and metrics to determine the health of your eTMF
  • Generate and manage automated workflow to reduce manual effort and obtain key insights
  • Take advantage of the full capabilities of the platform you adopt
  • Change management for long term TMF culture transformation
  • How to achieve a positive TMF culture change with many completing complexities
  • Renew TMF to improve processes
  • Evaluate and understand the needs to transition to eTMF
  • Define the requirements and controls and articulate the ROI
  • Best practices to prepare for the RFP process
  • Execute truly integrated TMF plan to support your TMF process
  • Generate and manage automated workflow to gain the edge 
  • Ongoing cross checks practices to ensure completeness throughout the TMF
  • Identify threats to data integrity and compliance issues
  • Keep Up to Date with EMA and ALCOA Guidelines
  • Strategies to maintain processes in real-time as the TMF is being generated
  • Successful strategies to create CRO partnerships that last
  • Build out relationships with internal change management
  • Techniques to develop clear expectations before during and until TMF transfer to the Sponsor
  • Optimize your eTMF efficiency 
  • Demonstrate vendor oversight while also undertaking routine system maintenance activities
  • Think ahead: seamless execution of large-scale clinical trials with respect to TMF access and document management
  • What is periodic review and why is it important to your TMF
  • When and how is periodic review conducted
  • Periodic review for inspection readiness and archiving
  • Introduction and Definition of GDP according to ICH guidelines
  • Recognize the importance of methodical and organized documentation in research
  • Some challenges while filing in TMF
  • GDP and maintaining TMF compliant and complete
  • Structure contents for accessibility, storage and quality for successful eTMF archiving
  • Address regulatory challenges facing archiving such as low data integrity, data immutability and retention periods
  • Learn methodologies to digitally preserve and actively manage documents on an ongoing basis