Managing Service Providers Including CRO and CMOs Oversight to Comply with ICH GCP R3 Training Course (April 18-19, 2024) - ResearchAndMarkets.com
29 Feb 2024
DUBLIN--(BUSINESS WIRE)--The "Managing Service Providers including CRO (Contract Research Organisation) and CMOs oversight to comply with ICH GCP (Good Clinical Practice) R3 Training Course" conference has been added to ResearchAndMarkets.com's offering.
'Managing Service Providers including CRO (Contract Research Organisation) and CMOs oversight to comply with ICH GCP (Good Clinical Practice) R3 Training Course'
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.
In 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
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.
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
Speakers:
Laura Brown
Pharmaceutical QA and Training Consultant
Dr Laura Brown MBA, BSc,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 in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including "The Planning of International Drug Development", in the Clinical Research Manual, Euromed and the "Impact of Brexit", RQA Journal 2017.
For more information about this conference visit https://www.researchandmarkets.com/r/qd6evl
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