Management Forum Logo

Presented by
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

★★★★★ "Dr Laura Brown is an excellent speaker with deep expertise in clinical trials research regulatory re... more (16)"

18-19 April 2024
+ 24-25 June 2024, 17-18 October 2024 »

from £1099

Need help?  Enrol or reserve

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.

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)

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.

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

The Managing Service Providers including CRO and CMOs oversight to comply with ICH GCP R3 course will cover:

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

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
LB Training and Development Ltd

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

18-19 April 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 13594

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

Until 14 Mar

View basket 

 
Not ready to book yet?

for 7 days, no obligation

24-25 June 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 13783

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

Until 20 May

View basket 

 
Not ready to book yet?

for 7 days, no obligation

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

Until 12 Sep

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.

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


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.

Oct 19 2023

Vincenzo Velleca
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
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
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
Senior Vendor Management Coordinator , IQVIA

Oct 17 2022

Greater understanding of the oversight mechanisms of vendors.

Dominic O'Hare
Associate Director, Norgine

Oct 8 2020

Laura is a great mentor. All aspects were good.

Udaya Toti
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
Senior Project Coordinator, Bavarian Nordic GmbH

Oct 3 2019

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

Valentina Cenacchi
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
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
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
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
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
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
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
Manager of Product Development and Operations, Mundipharma Research Ltd

Sep 19 2016

Everything was really nice

Arnaud Delforge
UCB Pharma S.A.

United Kingdom

  • AstraZeneca
  • Biogen
  • Blue Earth Diagnostics
  • BTG PLC
  • Cambridge Glycoscience
  • Cepheid
  • Dstl
  • Dstl IP
  • GlaxoSmithKline
  • GlaxoSmithKline Consumer Healthcare
  • GW Pharmaceuticals
  • GW Pharmaceuticals Ltd
  • GW Research Ltd
  • Intercept Pharmaceuticals
  • Ipsen Biopharm Ltd
  • Ipsen Ltd
  • IQVIA
  • Jazz Pharmaceuticals
  • Management Revisions Limited
  • MiNA Therapeutics
  • Mundipharma Research Limited
  • Mundipharma Research Ltd
  • Mundipharma Research Ltd.
  • Mylan Pharmaceuticals
  • Norgine
  • Norgine Ltd
  • Orchard Therapeutics
  • Panacea Pharma Projects
  • PPD
  • Procter & Gamble Technical Centres Limited
  • Regeneron
  • Regeneron Pharmaceuticals
  • Smith & Nephew Wound Management
  • SynOx Therapeutics UK Ltd
  • Takeda
  • Takeda Development Centre Europe Ltd
  • Vectura
  • Vectura Group plc
  • Vectura Ltd
  • Zentrale Tech

Italy

  • Chiesi Farmaceutici
  • Chiesi Farmaceutici S.p.A
  • Chiesi Farmaceutici S.p.A.
  • Chiesi Farmaceutici SpA
  • Fidia Pharma
  • Menarini Ricerche S.p.A.
  • Menarini Ricerche Spa
  • Merck
  • Zambon SpA

United States of America

  • Agios Pharmaceutical
  • Bluebird Bio
  • CSL Behring
  • Dicerna
  • Duke Clinical Research Institute
  • Jazz Pharmaceuticals
  • MEI Pharma
  • Renaissance Lakewood LLC
  • Taiho Oncology InC

Germany

  • Bavarian Nordic GmbH
  • Bayer AG
  • Bionorica GmbH
  • Biotest AG
  • Boehringer Ingelheim Ltd
  • Boehringer Ingelheim Vetmedica GmbH
  • Grünenthal GmbH
  • Medac GmbH

Spain

  • FAES FARMA, S.A.
  • Ferrer Interancional, S.A.
  • Ferrer Internacional
  • GAT Therapeutics
  • Grupo Ferrer Internaional S.A.
  • Ipsen Pharma SA

Switzerland

  • F. Hoffmann – La Roche AG
  • Hillevax GmbH
  • MSD Werthenstein BioPharma GmbH
  • ObsEva Sa
  • PTC Therapeutics Switzerland GmbH
  • Takeda Pharmaceuticals International AG

Denmark

  • Ferring Pharmaceuticals A/S
  • Novo Nordisk
  • Novo Nordisk A/S
  • Novo Nordisk A/S Denmark

Austria

  • Hookipa Biotech
  • Hookipa Biotech GmbH
  • Lundbeck Austria GmbH

Belgium

  • Estetra SPRL
  • UCB Pharma S.A.
  • UCB Pharma SA

France

  • Goapharma
  • Institut De Recherches Internationales Servier
  • Ipsen Ltd

Sweden

  • Hansa Medical AB
  • Sobi
  • Xbrane Biopharma

India

  • Cipla Ltd
  • Zoetis Pharmaceutical Research Pvt Ltd

Netherlands

  • Dechra
  • Merus N.V.

Czech Republic

  • Sotio Biotech a.s.

Finland

  • Vetcare Oy

Hungary

  • Gedeon Richter

Ireland

  • Teva Pharmaceuticals Ireland

Israel

  • Perrigo Israel Pharmaceutical Limited

Japan

  • Sumitomo Dainippon Pharma

Malta

  • Orphalan Ltd

Portugal

  • Viagens Abreu SA

South Africa

  • Aspen Pharmacare Holdings

Enrol or reserve

Run Managing Service Providers including CRO and CMOs oversight to comply with ICH GCP R3 Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy