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06-07-2020 (Online Course)

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Online Course: Management Strategies for Vendor Oversight

5-week online course | 2 hours per week

2 March – 3 April 2020
6 July – 7 August 2020

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EARLY BIRD RATE $995 + GST (SAVE $200) // PLEASE SEE PRICING FOR MORE DETAILS.

overview

It is essential for industry to employ efficient and accurate strategies for monitoring outsourced clinical trials to minimise the chances of receiving 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 essential 10-module course will provide a crucial overview of your responsibilities as a sponsor, giving you the knowledge, you need to ensure quality oversight over 5 weeks.

What Will You Learn?

  • Introduction to the complexities of vendor selection, management and oversight
  • Review of different outsourcing strategies and models
  • Different outsourcing models from strategy, through vendor selection and effective implementation
  • Comprehend your responsibilities as the sponsor both from GCP perspective and from vendor management perspective
  • Identify the right level of management and oversight
  • Understand the outsourcing strategies for selecting, monitoring and communicating with your service providers

Who Should Attend?

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

pricing

Packages Price
Online Course$1195+GST
Packages Price
Online Course$1195

2 March – 3 April 2020
Early Bird rate: $995 + GST (Save $200). Expires by 24 Jan 2020.
Standard rate: $1,195 + GST.

6 July – 7 August 2020
Early Bird rate: $995 + GST (Save $200). Expires by 29 May 2020.
Standard rate: $1,195 + GST.

 

Special rate $956 + GST (per person) when you book for four or more participants, please call us today on 02 9080 4307 or email training@informa.com.au to take advantage of this offer.

 


 

Bookings outside of Australia
Note: If you’re an international customer based outside of Australia, please select the International (non-GST) package, GST will be excluded.

trainer

Julianne Hull

Webinars

Free webinars that may be interesting for you…

Risk Management in Clinical Outsourcing

Managing risk is essential in good oversight of a clinical trial. In this webinar, the following points were discussed:

  • Risk Management for Outsourcing
  • Risk Identification
  • Risk Impact Mitigation through Risk Management
  • Risk Management Plan

This session was led by Julianne Hull. 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).

 


Management of your Vendors – Sponsor Responsibility

This webinar explores upcoming changes to Sponsor responsibility with the latest developments in ICH E6 Revision 2.

Over c.30 minutes, learn about the following:

  • Understand the ICH E6 Revision 2 changes
  • Explore how this will place a greater emphasis on Vendor oversight
  • Investigate ways to navigate these changes for Sponsors

Led by John Shillingford, trainer for PTI’s Effectively Managing Vendor Oversight training course.

Benefits of an Online Academy Course

  • Learn and apply – implement what you learn during the course
  • Become part of a professional learning community – discuss any problems with students and/or the trainer
  • Time effective – bitesize chunks so it does not impact on your normal working day
  • Cost effective – no travel expenses
  • Grow as a team – with multiple licenses your team can access the course and learn together, no matter where they are in the world

Online Academy Video

FAQs

Do sessions go out live?
No, all content is recorded and a set number of modules are released per week. You have unlimited access to module content once it has been released for the duration of the course and an additional two months.

Can I join after the course start date?
Yes, because modules are not live and all content is recorded you can catch up. Please contact us at training@informa.com.au to enquire about joining a course after the start date.

Can I still take part if I’m away for part of the course run?
Yes. Online Academies provide a flexible learning format. As modules are not released live and are available for review, you will be able to catch up.

How long is my enrolment on the course?
You are enrolled on the course for the period that modules are being released and the trainer is active on the discussion forum (this varies from course to course – between 3 – 8 weeks) and for an additional 2 months after this to review course content.

Who do I contact if I have any problems while the course is running?
You should contact PTI.MDTI.ATI-online@informa.com

When will I receive my log-on details for the course?
Once you have paid, a member of the team will be in touch with your log-in details. We must receive payment for you to access the course.

How can I access the content?
Content is hosted on our Learning Management System, which you access using your device. A link will be provided to you with your log-in details.

What if I need extra time on the course?
Please contact us at training@informa.com.au if you would like extra time on your course beyond the enrolment period. Extra time is subject to approvals and fees may apply.

About PTI - Pharmaceutical Training International

PTI is a global interactive training partner committed to the personal progression of aspiring life science professionals. We have a network of expert trainers who have a minimum of 10 years’ industry experience to meet your training requirements and all our courses are CPD certified.

Our Promise
Our vision is to enhance key skills and competencies to drive continuous innovation and accelerate drug development. When you invest in a PTI course we want you to feel secure, inspired and ready to take on new challenges.

CPD Certified
After completing a PTI course, you will be awarded with the CPD Certification certificate. This is a recognised independent CPD accreditation compatible with global CPD principles.

The Certificate of Achievement provides proof that you have taken the course and can be used on your CV or work portfolio.

Course Outline

Module 1: Introduction to outsourcing

  • The basics of outsourcing models and strategies
  • What to outsource: selection, goals and benchmarking
  • Vendor selection & management essentials to include timeframes
  • Regulatory Requirements and Quality expectations
  • Basics of vendor oversight and vendor management?
  • Metrics to drive transparent outsourcing
  • Vendor Governance

 

Module 2: Meeting regulatory expectations

  • Examining EU and US regulatory expectations and requirements
  • Exploring the evolution of vendor oversight: sponsors maintaining full accountability even with the complexity of outsourcing
  • Understanding transfer of obligations rather than transfer of responsibilities
  • Case studies: Examples of cases where the sponsor has failed to comply with regulation / received warning letters
  • How can sponsors ensure meeting regulatory expectations?

 

Module 3: Selection of the right outsourcing partners

  • Start with the end goal as a focus
  • Selecting a partner to fit your defined strategy
  • RFI, RFP
  • Bid Defence
  • Vendor capabilities assessment
  • Site inspections
  • Financial assessment and mock bids
  • Cost management versus getting it right first time
  • Core elements for contracts
  • Quality Agreements
  • Identifying, understanding and managing risk

 

Module 4: Vendor management: What are the key components of vendor management?

  • Vendor management: What are the key components of Vendor Management?
  • RACI
  • Ensuring and enabling operational deliverables
  • Monitoring and documentation of goals, deliverables and quality
  • What is the overarching concept for vendor management?
  • Operational Metrics
  • Achieving effective management across multiple service providers
  • Issue management and effective escalation processes

 

Module 5: Vendor oversight: 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

 

Module 6: What is governance? Implementing an effective governance structure

  • Ensuring organizational alignment to outsourcing strategy
  • What is required for effective governance of vendors
  • Designing a model to effectively manage and oversee multiple vendors
  • Roles and responsibilities in vendor management
  • Ensuring complementary relationships between QA and outsourcing
  • Business continuity

 

Module 7: Risk Management for Clinical Outsourcing

  • Risk Management for Outsourcing
  • Risk Identification
  • Risk Impact Mitigation through Risk Management
  • Risk Management Plan

 

Module 8: Maintaining healthy business relationships

  • Success strategies for effective communication
  • The right level of transparency
  • Overcoming challenges with change management
  • Case studies: Differing approaches taken by vendors

 

Module 9: Using metrics effectively when outsourcing

  • Metrics to measure your performance
  • Metrics to measure vendor’s performance
  • Metrics to drive transparency
  • Metrics to drive trust

 

Module 10: High level legal and financial considerations when outsourcing

  • Development of a contract
  • Key documents
  • Legal terms
  • Typical legal issues and how to overcome them
  • Financial Oversight

when & where

02 Mar - 03 Apr 2020

Online Course

06 Jul - 07 Aug 2020

Online Course

On-site & in-house training

Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?

Talk to us about an on-site/in-house & customised solution.

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