NEW: Live virtual Instructor-led Training Course
This training workshop will take place in a virtual format via a digital platform. Bite-sized training sessions of 2 hours spread across 1-2 weeks; start date is 9th June 2020. Delivered at set times with live trainer interaction enable you to ask questions and discuss theory to ensure a comprehensive understanding.

This virtual training workshop is designed for those working/interacting with vendors to deliver your clinical trials. How do you ensure you manage them to optimise your clinical trial delivery? What is required for compliant vendor oversight? What could put you at risk of inspection findings? Do you require a governance system with your vendors? How should you implement this for your outsourcing model and how will it add value? What is the best approach to maintain healthy business relationships when outsourcing? How do you drive performance transparency through use of metrics?

Course Objectives

• Understand the key components of vendor management and vendor oversight
• Learn about governance and how to implement an effective structure
• Discuss risk management approaches when outsourcing your clinical trials
• Describe different aspects of vendor oversight including third parties, local and emerging economies
• Implement metrics to drive performance and transparent vendor oversight
• Discuss the evidence a sponsor requires to convince a regulator you maintain control and oversight

Interactive activities (exercises, break-out groups, polls, open discussions) are core part of each module to help you to test and confirm you have met the learning objectives.

Course Modules

Module 1: 9th June – 09:30-11:45 am (2.15hrs)
• Introduction
• Vendor Management vs Vendor Oversight
• Vendor Oversight: What are the key components?

Module 2: 11th June – 09:30-11:30 am (2 hrs)
• What is Governance and how to Implement an effective Government Structure
• Risk Management when Outsourcing

Module 3: 15th June – 09:30 – 11:45 am (2.15 hrs)
• Maintaining Healthy Business Relationships to Support Effective Management and Oversight
• Regulatory Inspections when Outsourcing
• Summary, Action Planning, Takeaways

Who should attend?

This course is designed for anyone involved in or those seeking a better understanding of vendor management and vendor oversight: Clinical Development Staff, including those working in Clinical Outsourcing, Contracts and Outsourcing, Clinical Quality Assurance, Clinical Quality Control, Clinical Operations, Vendor Management, Global QA/Compliance and Regulatory Affairs.

Course Leader

Julianne Hull, with 30 year’s experience in clinical development, Julianne has successfully held global leadership roles in vendor management/outsourcing and clinical operations for several large and medium pharmaceutical companies (Pfizer, Wyeth, Marion Merrell Dow, Biogen Idec and Ipsen). Julianne is now CEO of WenStar Enterprises, a company she formed to provide consultancy to the pharmaceutical industry in the areas of clinical outsourcing and operations.

Continuing Education

This course is accredited by the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM).

Fee:

Registration Fee: CHF 790.00 + 7.7% VAT
15 % reduction for members of SwAPP and SBA
Special fees for CTC employees
Please contact training@ctcresourcing.com

The fee includes course documentation. Upon completion of the online survey participants will be able to get their certificate of attendance.
Payment: After registration, you will receive confirmation and an invoice with instructions on how to complete the bank transfer. Full prepayment is needed prior to the course.

Cancellation Policy:

• Cancellations received more than 14 days before course: 100% refund less bank charges & cancellation fee of CHF 50.00
• Cancellations received 7-14 days before the course: 50% refund
• Cancellations received 7 days before the course: no refund
In case of no show, no refund will be made.

Document:

VM-VO_pgm-flyer.pdf

If you have NOT received an official confirmation 7 days after registering, please contact training@ctcresourcing.com.

THANK YOU!