Managing Service Providers including CRO and CMOs Oversight to Comply with ICH Good Clinical Practice - 2 Day Online Certified Training Course

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Dec 05, 2023, 20:30 ET

DUBLIN, Dec. 5, 2023 /PRNewswire/ -- The "Managing Service Providers including CRO (Contract Research Organisation) and CMOs oversight to comply with ICH GCP (Good Clinical Practice) R3 Training Course" has been added to ResearchAndMarkets.com's offering.

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)

Certification:

CPD: 12 hours for your records
Certificate of completion

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.

Course Agenda:

Day 1

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

Day 2

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

For more information about this conference visit https://www.researchandmarkets.com/r/rtxgra

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