Learn strategies for effective management of clinical outsourcing to ensure regulatory compliance
Course Overview
It is essential for industry to employ efficient and accurate strategies for monitoring outsourced clinical trials to ensure they are being conducted to the high standards required for patient safety. If not done correctly pharma companies may receive warning letters from competent authorities. Companies should have robust structures in place for successful vendor selection, contract design, quality monitoring and risk minimisation when outsourcing clinical trials to remain compliant.
Using a combination of theory and practical examples, this interactive 2-day course will provide a crucial overview of your responsibilities as a sponsor, giving you the knowledge you need to ensure quality oversight. You will learn the key skills and competencies required to effectively manage your trials such as project management, stakeholder management, vendor oversight and management, and monitoring strategies.
What will you learn?
Regulatory Requirements
Regulatory Requirements
Get critical updates in regulatory expectations and requirements for vendor oversight
Critical Success Factors
Critical Success Factors
Determine critical success factors for selecting vendors and designing contracts
Quality Metrics
Quality Metrics
Discover key concepts for successful governance of oversight
Establish best practices for monitoring and implementing quality metrics
Project Management Strategies
Project Management Strategies
Implement time-saving project management strategies to ensure cost-effective vendor oversight
Case Studies
Case Studies
Learn from real life case studies: Discover when and why warning letters have been received in the past
Practical Exercises
Practical Exercises
Benefit from interactive practical exercises, designed specifically to enhance your oversight strategies
Who is this course for?
All professionals who are involved in vendor oversight will benefit from this course, including:
- Clinical Outsourcing
- Contracts and Outsourcing
- Clinical Quality Assurance
- Clinical Quality Control
- Clinical Operations
- Vendor Management
- Global QA/Compliance
- Regulatory Affairs
CPD Certified
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.
