Presented by
Management Forum

Managing Vendor/CRO/CMO Oversight

Optimising oversight for inspection compliance

17-18 Jan 2022 + 3 more dates

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

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)

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.

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The Managing Vendor/CRO/CMO Oversight course will cover:

Background to the CRO industry and meeting regulatory expectations

  • Outsourcing today for the pharma industry
  • Different models of outsourcing in the pharma industry
  • Examine EU and FDA expectations for outsourcing in the pharma industry
  • The potential benefits and drivers of outsourcing

    Effective oversight and management: how CROs and sponsors can work successfully on R&D projects

    • Challenges of working with CROs to ensure effective management and oversight

    Vendor/CRO selection – an overview of selection and bidding processes including assessing the competency of the CRO/vendor

    • Evaluating responses to the RFP
    • Pre-qualification of vendors and vendor audits
    • Contracts, negotiations and partnering with CROs
    • All or none – what should you outsource?
    • Sponsor responsibilities for the clinical study vs the CRO
    • Writing the RFP

    Managing vendor/CRO project set-up

    • Building an effective relationship with the CRO while providing sponsor oversight and a working escalation of issues
    • How to set the stage so the CRO focuses on quality – the quality/oversight plan
    • Briefing the CRO to be able to work successfully in the pharma industry
    • Clarity of roles and responsibilities

    Oversight preparation, planning and clarity of roles and responsibilities

    • Project set-up, planning and initiation with CROs for R&D projects
    • Training CROs
    • Which SOPs should CROs use?
    • Clarity and communications with CROs
    • Risk assessment tools
    • Tools and techniques for managing CRO performance – understand the KPIs/ dashboards/report processes that can be set up in order to manage regular meetings with CROs/vendors

    Ongoing oversight and management

    • Tracking and measuring CRO progress and performance
    • Ongoing training and integrating new CRO staff
    • Auditing CROs
    • Maintaining effective communication with your CRO
    • Progress and update meetings/TCs with CROs
      • Agendas for meetings with CROs to include update reports
      • Discussion of billing issues with CROs
      • Deliverables and analysing performance trends
      • 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 the CRO in the future

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    Laura Brown

    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

    Book Managing Vendor/CRO/CMO Oversight Classroom/Live online training

    17-18 Jan 2022

    Classroom
    London venue TBC

    00:00-00:00 UK (London)
    Course code 11904

    • GBP 1,299 1,499
    • EUR 1,819 2,099
    • USD 2,026 2,338

    Until 13 Dec

    • 2 days classroom-based training
    • Meet presenters and fellow attendees in person
    • Lunch and refreshments provided
    • Download documentation and certification of completion
    • Fair transfer and cancellation policy

    In your basket 

    11-12 Apr 2022

    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 11605

    • GBP 1,099 1,299
    • EUR 1,579 1,859
    • USD 1,786 2,098

    Until 07 Mar

    In your basket 

    11-12 Jul 2022

    Classroom
    London venue TBC

    00:00-00:00 UK (London)
    Course code 11905

    • GBP 1,299 1,499
    • EUR 1,819 2,099
    • USD 2,026 2,338

    Until 06 Jun

    • 2 days classroom-based training
    • Meet presenters and fellow attendees in person
    • Lunch and refreshments provided
    • Download documentation and certification of completion
    • Fair transfer and cancellation policy

    In your basket 

    17-18 Oct 2022

    Live online

    00:00-00:00 UK (London) (UTC+01)
    01:00-01:00 Paris (UTC+02)
    19:00-19:00 New York (UTC-04)
    Course code 11720

    • GBP 1,099 1,299
    • EUR 1,579 1,859
    • USD 1,786 2,098

    Until 12 Sep

    In your basket 

    Reviews of IPI's Managing Vendor/CRO/CMO Oversight training course


    Laura is a great mentor. All aspects were good.

    Oct 8 2020

    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.

    UK

    • AstraZeneca
    • Biogen
    • BTG PLC
    • Cambridge Glycoscience
    • GlaxoSmithKline
    • GlaxoSmithKline Consumer Healthcare
    • GW Pharmaceuticals
    • GW Pharmaceuticals Ltd
    • GW Research Ltd
    • Intercept Pharmaceuticals
    • Ipsen Biopharm Ltd
    • Jazz Pharmaceuticals
    • Management Revisions Limited
    • Mundipharma Research Ltd
    • Mylan Pharmaceuticals
    • Orchard Therapeutics
    • Panacea Pharma Projects
    • PPD
    • Procter & Gamble Technical Centres Limited
    • Regeneron
    • Regeneron Pharmaceuticals
    • Smith & Nephew Wound Management
    • Takeda
    • Takeda Development Centre Europe Ltd
    • Vectura
    • Vectura Group plc
    • Vectura Ltd

    Germany

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

    Italy

    • Chiesi Farmaceutici
    • Chiesi Farmaceutici S.p.A
    • Chiesi Farmaceutici S.p.A.
    • Chiesi Farmaceutici SpA
    • Menarini Ricerche S.p.A.
    • Merck

    United States of America

    • Agios Pharmaceutical
    • Bluebird Bio
    • CSL Behring
    • Dicerna
    • Duke Clinical Research Institute
    • Renaissance Lakewood LLC

    Denmark

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

    Spain

    • Ferrer Interancional, S.A.
    • Ferrer Internacional
    • Grupo Ferrer Internaional S.A.
    • Ipsen Pharma SA

    Switzerland

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

    Belgium

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

    Austria

    • Hookipa Biotech GmbH
    • Lundbeck Austria GmbH

    France

    • Goapharma
    • Institut De Recherches Internationales Servier

    India

    • Cipla Ltd
    • Zoetis Pharmaceutical Research Pvt Ltd

    Sweden

    • Hansa Medical AB
    • Xbrane Biopharma

    Finland

    • Vetcare Oy

    Ireland

    • Teva Pharmaceuticals Ireland

    Israel

    • Perrigo Israel Pharmaceutical Limited

    Japan

    • Sumitomo Dainippon Pharma

    Portugal

    • Viagens Abreu SA

    South Africa

    • Aspen Pharmacare Holdings

    Enrol now

    Multiple colleagues?
    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
    Training expert

    +44 (0)20 7749 4749

    inhouse@ipi.academy