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Management Forum

Managing Service Providers including CRO (Contract Research Organisation) and CMOs oversight to comply with ICH GCP (Good Clinical Practice) R3 Training Course

Optimising oversight for inspection compliance.

★★★★★ "Content was great. Speaker was wonderful!"

17-18 October 2024
+ 6-7 February 2025, 23-24 June 2025, 16-17 October 2025 »
from £1099

Need help? Enrol or reserve

Format: Live online
CPD: 12 hours for your records
Certificate of completion

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Course overview

With regulatory inspectors increasingly finding issues with vendor oversight by sponsor organisations, it is becoming even more important for the pharmaceutical industry to employ efficient and accurate strategies for managing outsourced activities. A company’s ability to identify and select the right CRO/ vendor for the right project and manage them efficiently and effectively will help to ensure compliance with the regulator’s expectations.

On this course you will learn how to prepare a request for proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource. You will also cover the techniques for successfully managing CROs/ vendors and the shared responsibilities required by the sponsor and the service provider. Managing CRO performance issues will also be discussed.

The course is equally useful to CROs/other vendors and consultants to understand how to work effectively with sponsor organisations.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

Understand how to effectively manage CROs/vendors used in the pharma industry
Build an understanding of your responsibilities as the sponsor and identify the right level of management and oversight
Discuss how to put in place a robust CRO/vendor selection process
Discover tools and processes to manage CROs and other vendors
Measure CRO performance including metrics and key performance indicators (KPIs)

Who should attend?

This event is designed for personnel involved in CRO/vendor management and oversight in the pharmaceutical, biotechnology, animal health and medical device industries including those working in clinical research, regulatory affairs, pharmacovigilance, manufacturing, clinical outsourcing, contracts, quality, clinical operations, vendor management and global QA/compliance. It will also be relevant for outsourcing, purchasing, finance and contract management staff who participate in the RFP process who will find this course a valuable introduction or refresher course focusing on best practice.

This course will also help CRO/vendor personnel to work more successfully with pharmaceutical, biotechnology and medical device companies through gaining a much clearer understanding of their needs when outsourcing.

Enrol or reserve

This course will cover:

Day 1
Day 2

Background to the CRO industry and meeting regulatory expectations

Outsourcing today for the biopharma industry
Different models of outsourcing
Challenges of working with CROs/Vendors and solutions
Core components of Vendor Governance
The potential benefits and drivers of outsourcing
Outsourcing Trends

Oversight of CROS/Vendors and meeting regulatory inspectors’ expectations

Understanding Oversight
Key elements of Vendor Oversight
Examples of Vendor Oversight documents
Examine EU and FDA expectations for outsourcing in the pharma and biopharma industry

Building an effective relationship

Factors critical for a successful relationship
Building trust

Vendor/CRO selection – an overview of selection and bidding processes

Identifying Vendors/ CROs
Preparing the RFP
Evaluating responses to the RFP
Pre-qualification of vendors and vendor audits
Writing the RFP
Contracts with Vendors/CROs
Bid defence meetings

Vendor/CRO selection – an overview of selection and bidding processes - continued

Managing vendor/CRO project set-up

How to set the stage so the CRO focuses on quality
Effective Kick-off meetings
Training CROs
Which SOPs should CROs use?
Risk assessment
Tools and techniques for managing CRO performance
Understand the KPIs/ dashboards
Communications with CROs

Ongoing oversight and management

Tracking and measuring CRO progress and performance
Ongoing training and integrating new CRO staff
Maintaining effective communication with your CRO
Report processes to manage CROs/vendors
Progress and update meetings/TCs with CROs
Meetings with CROs
Update reports
Auditing CROs
Escalation
Troubleshooting problems with CROs – common problems and possible solutions

End of project oversight: reviewing CROs during and at the end of the project

Review meetings
Feedback and learnings for using in the future
Evaluation of suppliers

Enrol or reserve

Laura Brown
Independent Pharmaceutical Consultant

Dr Laura Brown is an independent pharmaceutical QA and training consultant and the Senior Lecturer for the MSc in Clinical Research, School of Pharmacy, University of Cardiff. Laura is an expert in outsourcing pharmaceutical research projects including CRO selection, management and oversight audit and management. She has more than 20 years’ experience in the pharmaceutical industry in a number of senior roles and has worked for several companies, including GSK, Hoechst Marion Roussel and Phoenix International in outsourcing pharmaceutical projects. She has worked in several vendor selection and management roles which have included reviewing quality and performance of CROs and has advised companies on how to implement quality systems for CRO selection and management.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

17-18 October 2024

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 13941

GBP 1,299
EUR 1,869
USD 2,129

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

6-7 February 2025

Live online

Course code 14625

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 02 Jan

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

23-24 June 2025

Live online

Course code 14771

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 19 May

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

16-17 October 2025

Live online

Course code 15016

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 11 Sep

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Managing Service Providers including CRO and CMOs oversight to comply with ICH GCP R3 training course

Content was great. Speaker was wonderful!

Apr 18 2024

Elsje Du Preez Switzerland
Manager Vendor Management & Administration, Hillevax GmbH

Oct 19 2023

The speaker demonstrated a deep knowledge of all themes presented during the course. Sessions were well organized and enough time was dedicated to each of them.

Vincenzo Velleca Italy
Global Safety Operations, Zambon SpA

Jul 11 2022

Dr Laura Brown is an excellent speaker with deep expertise in clinical trials research regulatory requirements and expectations!

Virginia Suarez United States of America
Executive Director, Clinical Quality, MEI Pharma

Apr 11 2022

Understanding RFP and RFI were achieved. KPI session was very helpful and I learnt about oversight plan which I never knew about. Laura was very good, provided great content of the subject matter and discussions included were good and relevant.

Stephanie Yearwood United Kingdom
Senior Vendor Management Coordinator , IQVIA

Apr 11 2022

Understanding RFP and RFI were achieved, KPI session was very helpful and I learnt about oversight plan which I never knew about... Laura was very good, provided great content of the subject matter and discussions included were good and relevant.

Stephanie Yearwood United Kingdom
Senior Vendor Management Coordinator , IQVIA

Oct 17 2022

Greater understanding of the oversight mechanisms of vendors.

Dominic O'Hare United Kingdom
Associate Director, Norgine

Oct 8 2020

Laura is a great mentor. All aspects were good.

Udaya Toti United States of America
Sr. Manager - Formulation Development, Renaissance Lakewood LLC

Oct 8 2020

It was a very good webinar especially due to Laura´s way of presentation. The balance between information given by Laura and the break-out sessions were really great.

Alexandra Ludvigsen Germany
Senior Project Coordinator, Bavarian Nordic GmbH

Oct 3 2019

The course was well done and the speaker was well prepared and enthusiastic.

Valentina Cenacchi Italy
Senior PK scientist, Chiesi Farmaceutici SpA

Apr 8 2019

It was very good course. There are too many good points to list! The course was very relevant to my job and will help me in most aspects of my work. Laura was very clear and knowledgeable. She empowers participants for discussion and welcomed feedback from all participants.

Kaushik Patel United Kingdom
Category Manager, BTG PLC

Oct 3 2019

The speaker was very friendly and engaging and I liked the interactive nature of the course.

Richard O'Callaghan Ireland
Quality Officer, Teva Pharmaceuticals Ireland

Oct 4 2018

Laura was very clear, encouraged active participation and welcomed feedback from all participants. I thought the two days were very well spent. I learned a lot, Laura obviously knows the content very well and it was a great opportunity to network with people from other companies, sometimes struggling with similar issues.

Wendy Fiander United Kingdom
Director Clinical Operations, Orchard Therapeutics

Mar 20 2018

It was nice but very dependent on the other participants and where they come from including experience.

Louise Hickman Denmark
Event Adjudication Adviser, Novo Nordisk A/S

Oct 4 2018

A very good course with a lot of good information. Speaker was very knowledgeable!

Jenny Dahlberg Sweden
Clinical Research Coordinator, Hansa Medical AB

Oct 2 2017

This is a great opportunity to identify whether your system for vendor management is in line with the current expectation and what improvement can be made.

Maria Calvo Subirats Spain
GCP&GVP Responsible (QA Unit), Ferrer Internacional

Sep 19 2016

Very good course, a nice balance of lecture and open group discussions. Being a small group of attendees, everyone had the chance to share their thoughts/learnings.

Shaun Pope United Kingdom
Manager of Product Development and Operations, Mundipharma Research Ltd

Sep 19 2016

Everything was really nice

Arnaud Delforge Belgium
UCB Pharma S.A.