Regulatory Compliance seminar 2018 - Strategies for Effective Management and Oversight of Clinical Outsourcing to Ensure Regulatory Compliance

Strategies for Effective Management and Oversight of Clinical Outsourcing to Ensure Regulatory Compliance
Overview
Vendor Oversight is currently a hot topic as Sponsors and vendors aim to get to grips with what is really required. You don’t want to outsource and then expend multiple resources to manage and oversee your trial. As a vendor you want to get on with the outsourced clinical trial in the most effective way feasible without micromanagement from your sponsor company. What is required to compliantly and efficiently implement vendor oversight? What are the risks and challenges of not getting this right from the beginning? This course will aim to work through some of these challenging topics with time given to work through specific scenarios from the attendees.
Areas Covered in the Session
• Meeting Regulatory Expectations: recent industry and regulatory items that impact Vendor Oversight to include ICH E 6 R2
• Outsourcing models: what could work best for your organization
• Selecting the right providers for your outsourcing model
• What are the key components of Vendor Oversight
• Implementing an effective Governance Structure
• Implementing effective Vendor Oversight and Management
Learning Objectives
• Understand the regulatory requirements that impact Vendor management and Vendor Oversight including recent revisions
• Explore different Outsourcing Models and what they mean when implementing effective Vendor management and Oversight
• Explain the requirements for selecting vendors to meet your outsourcing requirements
• Describe expectations for Vendor Oversight and how to implement a practical vendor oversight plan
• Recognize the components of vendor governances and understand what is right for your organization
• Evaluate what makes excellent vendor management and oversight to support clinical trial delivery
Who Will Benefit
Those involved in or seeking a better understanding of vendor management and vendor oversight:
• Clinical Development staff including those working in Clinical Outsourcing
• Clinical Operations
• Contracts and Outsourcing
• Clinical Quality Assurance
• Clinical Data Management
• Vendor Management
• Global QA/Compliance and Regulatory Affairs
Agenda:
Lecture 1: Meeting Regulatory Expectations: recent industry and regulatory items that impact Vendor Oversight to include ICH E 6 R2
• Examine EU and US regulatory expectations and requirements with respect to outsourcing
• Review inspection findings with respect to outsourcing
• Case study: Example where the sponsor/CRO has failed to comply with regulation / received warning letters
• Explore the evolution of vendor oversight
Lecture 2: Outsourcing models: what could work best for your organization?
• Practical Exercise: outsourcing models
• Design outsourcing strategies fit for purpose
• Explore different outsourcing models
Lecture 3: Selecting the right providers for your outsourcing model
• Practical Exercise: Core components to selecting vendors
• Identify critical success factors for your outsourcing model
• Process for selecting vendors to fit your needs
• Practical Exercise: Negotiation of Scope of Work
Lecture 4: What are the key components of Vendor oversight
• Group discussion: What are the success factors for vendor oversight
• Explore, compare and contract Vendor Management and Vendor Oversight
Lecture 5: Implementing an effective Governance Structure
• What is Governance?
• Do you require Governance for your outsourcing model?
• Practical Exercise: Design governance for your outsourcing model
Lecture 6: Implementing effective Vendor Oversight and Management
• Measuring Vendor and Sponsor performance to drive delivery
• Practical Exercise: Identify Metrics and KPIs to measure for your outsourcing model
• Issue Management through resolution
• Planning to succeed outsourcing
Final Q&A to ensure meet attendees objectives
Speaker:
Julianne Hull
CEO,
Wenstar Enterprises
Julianne Hull is currently CEO of WenStar Enterprises a company she formed to provide training and consultancy to the pharmaceutical industry primarily in the areas of clinical outsourcing and clinical operations but also in other areas of clinical development.
With over 26 years’ 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). In these roles she has been an accomplished manager and motivator of staff based in China, India, Japan, Europe and US.
Location: London, UK Date: 10 September 2018 Time: 09:00 AM To 06:00 PM CEST
Venue: London Hilton on Park Lane 22 Park Ln, Mayfair, London W1K 1BE, UK
Price:
Until August 10, Early Bird Price: $599.00
From August 11 to September 08, Regular Price: $799.00
Register for 5 attendees Price: $1,797.00 Save: $1,198.00 (40%)
Register for 10 attendees Price: $3,294.50 Save: $2,695.50 (45%)
Registration Link:
https://www.traininng.com/seminar/strategies-for-e...
Contact us today!
Traininng.com LLC
traininngdotcom-AT-gmail.com
Phone:
US: (510) 962-8903
Zurich: +41 - 43 434 80 33
https://www.traininng.com