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Managing Vendor/CRO (Contract Research Organisation)/CMO (Contract Manufacturing Organisation) Oversight Training Course

Optimising oversight for inspection compliance

17-18 Jan 2022

& 11-12 Apr 2022 , 11-12 Jul 2022 , 17-18 Oct 2022

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Details

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.

Programme

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

    Presenter

    Laura Brown (More...)

    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.

    Book now

    Book now

    17-18 Jan 2022
    Face-to-face, (venue not yet confirmed)
    17-18 Jan 2022
    Face-to-face
    (venue not yet confirmed)
    GBP 1,499 1,299
    EUR 2,099 1,819
    USD 2,338 2,026
    Until 13 Dec*
    Enrol now
    to attend
    Face-to-face
    (venue not yet confirmed)
    • 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
    11-12 Apr 2022
    Live webinar
    11-12 Apr 2022
    Live webinar
    GBP 1,299 1,099
    EUR 1,859 1,579
    USD 2,098 1,786
    Until 7 Mar 22*
    Enrol now
    to attend
    Live webinar
    11-12 Jul 2022
    Face-to-face, (venue not yet confirmed)
    11-12 Jul 2022
    Face-to-face
    (venue not yet confirmed)
    GBP 1,499 1,299
    EUR 2,099 1,819
    USD 2,338 2,026
    Until 6 Jun 22*
    Enrol now
    to attend
    Face-to-face
    (venue not yet confirmed)
    • 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
    17-18 Oct 2022
    Live webinar
    17-18 Oct 2022
    Live webinar
    GBP 1,299 1,099
    EUR 1,859 1,579
    USD 2,098 1,786
    Until 12 Sep 22*
    Enrol now
    to attend
    Live webinar

    Learn more about our face-to-face and webinar training formats.

    * Note the early booking discount cannot be combined with any other offers or promotional code

    Continuing professional development

    This course qualifies for 12 hours for your CPD records.
    More about CPD

    Customised in-house training

    We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

    Contact us

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    Previous customers include...

    • Agios Pharmaceutical
    • AstraZeneca
    • Biogen
    • Bionorica GmbH
    • Boehringer Ingelheim Vetmedica GmbH
    • Chiesi Farmaceutici
    • Chiesi Farmaceutici S.p.A
    • Chiesi Farmaceutici S.p.A.
    • CSL Behring
    • Dicerna
    • Duke Clinical Research Institute
    • GlaxoSmithKline
    • GlaxoSmithKline Consumer Healthcare
    • Goapharma
    • GW Pharmaceuticals
    • Hookipa Biotech GmbH
    • Intercept Pharmaceuticals
    • Ipsen Biopharm Ltd
    • medac GmbH
    • Mylan Pharmaceuticals
    • Novo Nordisk
    • Novo Nordisk A/S
    • Panacea Pharma Projects
    • Procter & Gamble Technical Centres Limited
    • Takeda
    • Vectura
    • Vetcare Oy
    • Viagens Abreu SA
    • Xbrane Biopharma
    • Zoetis Pharmaceutical Research Pvt Ltd

    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 20

    Laura is a great mentor. All aspects were good.

    Udaya Toti, Sr. Manager - Formulation Development, Renaissance Lakewood LLC, Oct 20

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

    Valentina Cenacchi, Senior PK scientist, Chiesi Farmaceutici SpA , Oct 19

    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 19

    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, Apr 19

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

    Jenny Dahlberg, Clinical Research Coordinator, Hansa Medical AB, Oct 18

    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, Oct 18

    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, Mar 18

    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, Oct 17

    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 16

    Everything was really nice

    Arnaud Delforge, UCB Pharma S.A., Sep 16