Managing Vendor/CRO (Contract Research Organisation)/CMO (Contract Manufacturing Organisation) Oversight Training Course
Optimising oversight for inspection compliance
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.
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17-18 Jan 2022 Face-to-face, (venue not yet confirmed) |
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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* |
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11-12 Apr 2022 Live webinar |
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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* |
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to attend Live webinar |
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11-12 Jul 2022 Face-to-face, (venue not yet confirmed) |
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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* |
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to attend Face-to-face (venue not yet confirmed) |
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17-18 Oct 2022 Live webinar |
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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 |
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* Note the early booking discount cannot be combined with any other offers or promotional code