Virtual Classroom: Effective Vendor Management and Oversight in Clinical Research
June 15 @ 9:00 am - June 16 @ 12:30 pm CEST
This training will take place in a virtual format via a digital platform with live trainer interaction and interactive activities which will enable you to ask questions and discuss theory to ensure you have a comprehensive understanding of the course content.
This virtual course 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?
WHO SHOULD ATTEND?
This basic course is designed for anyone involved in vendor management and vendor oversight with up to one-year experience or those who have an interest in the topic or are seeking a better understanding of working with external vendors: 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.
With this course you will:
• 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
Activities are core part of this course to help you to test and confirm you have met the learning objectives for each session.
Module 1: 15th June – 09:00-12:30 CET
• What is Vendor Management and what is Vendor Oversight
• The many Aspects of Vendor Oversight
• What is Governance and how to Implement an Effective Government Structure
Module 2: 16th June – 09:00-12:30 CET
• Risk Management when Outsourcing
• Maintaining Healthy Business Relationships to Support Effective Management and Oversight
• Regulatory Inspections when Outsourcing
Julianne Hull, with 30 years’ experience in clinical development, Julianne has successfully held global leadership roles in vendor management/outsourcing clinical data management 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.
The combination of live trainer interaction, information sharing and opportunities for conversations and discussions of the theory will help ensure you have a comprehensive understanding of the course content.
This course is accredited by the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM).
The training will be delivered via digital platform. In order to get access you will need an internet connection, audio (from computer speakers or microphone), and a webcam (standalone or integrated with your monitor/laptop).
Registration Fee: CHF 680.00 + 7.7% VAT
15 % reduction for members of SwAPP and SBA
Special fees for CTC employees
Special rates available for PhD Students, please contact firstname.lastname@example.org
The fee includes course documentation and a course participation certificate
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.
• 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.
If you have NOT received an official confirmation 7 days after registering, please call CTC at 0041 61 695 88 66 or send an email to email@example.com.