The "New EU (European Union) GMP (Good Manufacturing Practice) Annex 1: Compliant Aseptic Operations Training Course" conference has been added to ResearchAndMarkets.com's offering.
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.
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. 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.
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
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
University of Cardiff
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/g644uv
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