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Managing Vendor/CRO/CMO Oversight Training Course: face to face & live webinar

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

8-9 Oct 2020

& 26-27 Apr 2021 , 7-8 Oct 2021

Book now

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 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 - day 1

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: 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

    Programme - day 2

    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 MBA, BSc (Biochemistry), BSc (Psychology), PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance and regulatory requirements in clinical trials in the pharmaceutical industry. She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials

    Book now

      attend Face to face attend Live webinar
    8-9 Oct 2020, Rembrandt Hotel, London
    8-9 Oct 2020 Rembrandt Hotel, London GBP 1,299.00
    EUR 1,819.00
    USD 2,026.00
    Until 27 Aug*
    Enrol now
    to attend
    Face to face
    GBP 1,099.00
    EUR 1,579.00
    USD 1,786.00
    Until 27 Aug*
    Enrol now
    to attend
    Live webinar
    26-27 Apr 2021, Venue not yet confirmed
    26-27 Apr 2021 Venue not yet confirmed GBP 1,299.00
    EUR 1,819.00
    USD 2,026.00
    Until 15 Mar 21*
    Enrol now
    to attend
    Face to face
    GBP 1,099.00
    EUR 1,579.00
    USD 1,786.00
    Until 15 Mar 21*
    Enrol now
    to attend
    Live webinar
    7-8 Oct 2021, Venue not yet confirmed
    7-8 Oct 2021 Venue not yet confirmed GBP 1,299.00
    EUR 1,819.00
    USD 2,026.00
    Until 26 Aug 21*
    Enrol now
    to attend
    Face to face
    GBP 1,099.00
    EUR 1,579.00
    USD 1,786.00
    Until 26 Aug 21*
    Enrol now
    to attend
    Live webinar

    Learn more about our different training formats.

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

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    Previous customers include...

    • Bavarian Nordic GmbH
    • Biogen
    • Bluebird Bio
    • Chiesi Farmaceutici SpA
    • Dicerna
    • Duke Clinical Research Institute
    • Ferring Pharmaceuticals A/S
    • GlaxoSmithKline
    • Goapharma
    • Hansa Medical AB
    • Hookipa Biotech GmbH
    • Ipsen Biopharm Ltd
    • Ipsen Pharma SA
    • Jazz Pharmaceuticals
    • medac GmbH
    • Merck
    • Mundipharma Research Limited
    • Mundipharma Research Ltd
    • Novo Nordisk A/S
    • Panacea Pharma Projects
    • Perrigo Israel Pharmaceutical Limited
    • PPD
    • Research and Markets
    • Sumitomo Dainippon Pharma
    • Takeda
    • Takeda Development Centre Europe Ltd
    • Takeda Pharmaceuticals International AG
    • Teva Pharmaceuticals Ireland
    • Viagens Abreu SA
    • Xbrane Biopharma

    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

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

    Valentina Cenacchi, Senior PK scientist, Chiesi Farmaceutici SpA , 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

    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

    A very good course with a lot of good information. Speaker was very knowledgeable! A bit to much time spent on the role play during start of day 2. Time would have been better invested in ongoing oversight and end of Project oversight.

    Jenny Dahlberg, Clinical Research Coordinator, Hansa Medical AB, 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