Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover subsequent questions and challenges

Introductory Module 1

60 mins

Vendor oversight and management overview

• Introduction to vendor oversight
• Why is it important?

Module 2

 120 mins

Meeting regulatory expectations when outsourcing

• Examining EU and US regulatory expectations and requirements, ICH proposed revisions
• Exploring the evolution of vendor oversight: sponsors maintaining full accountability even with the complexity of outsourcing
• MHRA GCP Guidelines
• Understanding transfer of obligations rather than transfer of responsibilities
• Case studies: Example where the sponsor/CRO has failed to comply with regulation / received warning letters
• How can sponsors ensure meeting regulatory expectations?
• Inspections
• Activity: Inspection readiness with vendors

Module 3

120 mins

Vendor management: What are the key components of vendor management?

• Outsourcing models
• What are the Key components of vendor Management?
• RACI
• Ensuring and enabling operational deliverables
• Monitoring and documentation of goals, deliverables and quality
• Achieving effective management across multiple service providers
• Activity: Design your ideal outsourcing model to include vendor management

Module 4

120 mins

What are the key components of vendor oversight?

• What is difference between vendor management and vendor oversight?
• What is defined as success for vendor oversight?
• Define your oversight philosophy
• Demonstrating control to inspectors
• Effective shared risk approaches to vendor oversight: ‘Skin in the game’
• Hands on/hands off – does it matter?
• Auditing strategy: Reaffirmation of vendor capabilities and CAPA management
• Activity: Outsourcing Oversight is easy

Module 5

120 mins

Risk management in clinical outsourcing

• Risk Management for Outsourcing
• Risk Identification
• Risk Impact Mitigation through Risk Management
• Risk Management Plan
• Activity: Risk identification

Issue management

• Who is responsible for issue management?
• Root Cause analysis
• Is there a clear escalation pathway?
• Tracing of issues to use for trending
• Activity: Root cause analysis

Module 6

120 mins

What is governance? implementing an effective governance structure for your models to drive all outcomes

• Ensuring organizational alignment to outsourcing strategy
• What is required for effective governance of vendors?
• Delegation through escalation
• Activity: Driving performance
• Using metrics effectively when outsourcing
• Why do you measure?
• What do you measure?
• Metrics to measure your performance
• Metrics to measure vendor’s performance
• Metrics to drive transparency
• Metrics to drive trust
• Metrics for quality management
• Activity:  We all love metrics

Module 7

120 mins

Maintaining healthy business relationships

• What Makes a Successful Business Relationship?
• Understanding Different Communication Styles
• Recognise that individuals have different communication styles including positive and negative body language, verbal tomes and eye contact
• Recognise how through excellent self-management you can build excellent business relationships
• Remember that listening and observing skills are critical to developing robust business relationships
• Activity: Observe

Off-shoring

• Benefits and Risks when Off-Shoring
• Where to Off-shore?
• Challenges
• Culture
• Activity: Will off-shoring work for you?

Module 8

120 mins

Improvements in management, oversight and governance you should implement

• Review 3 weeks post of the previous module

Julianne Hull – With 30+ years of global leadership experience within the pharmaceutical industry, Julianne has broad and in-depth knowledge of how Clinical Trials work. Having been a global leader for operations planning and vendor management within Wyeth she established and led the fora to ensure collaborative cross-functional delivery of all phase 1 to 3 clinical studies. Julianne has worked in the large, medium, and small pharma providing valuable perspectives on the varying constraints and enablers to project delivery.

Julianne delivers training programmes globally on several different clinical topics bringing her real-life experiences to the classroom. Julianne has an easy and interactive style which ensures the class engage and take the most from the training.