INTRODUCTION
This course will provide the participants with the specific methodology and management techniques to successfully outsource pharmaceutical programs that should then be more likely to be completed on time, within budget, and most importantly, with a high level of quality and performance. Participants will learn how the current external and internal forces are shaping the way projects will need to be delivered to be competitive and cost efficient given the dynamics and demands of the industry.
PROGRAM OBJECTIVES
- Increasing ability to identify and select the right vendor for the right job a
- Learning to write a Request for Proposal (RFP)
- Using RFP to find, evaluate and select the right CRO for the work they need to outsource
- Understanding the methodology for comparing and contrasting vendor responses to the RFP
- Learning techniques for successfully managing CROs and the shared responsibilities required by the sponsor and the service provider
WHO SHOULD ATTEND?
- Personnel in the pharmaceutical, biotechnology, medical device
- VPs, Directors, Managers and other personnel involved in selecting and managing CROs
- Outsourcing department staff
- Purchasing, finance and contract management staff
- CRO administration and management
PROGRAM OUTLINE
Introduction to Clinical Research Organizations
- Why outsource?
- What to outsource?
- Non-Clinical, Manufacturing and Clinical CROs
- Outsourcing entire functions
Vendor Selection Process
- How to find a CRO
- Criteria for selection
- RFP development
- Ways to compare and contrast before you select
- Evaluating available documentation
- Proposal review and evaluation
- Contract negotiation and award
Managing CROs
- Preparation, planning and positioning with CROs
- Study set-up, planning and initiation
- SOPs: your firm and CROs
- Formulating a study plan
- FDA and legal requirements of CROs
- Monitoring and evaluating methods and timelines of CROs
- Clarity and communications with CROs
- Realistic projections for projects, staff and CROs
Duties of the CRO, Sponsor and Trial Sites
- Global knowledge: U.S. vs. EU regulations and nuances
- How to ensure compliance with regulations, including
- GMP
- GCP
- GLP
- Auditing
- Collaborative tools and techniques
- Legal framework
- Auditing
- Troubleshooting
- Tackling problems and finding effective solutions
Permintaan Brosur penawaran Training
( Harga, Waktu dan Tempat)
silahkan Menghubungi kami.
Cs1 : +62812 2554 2418
Cs2 : +62857 2459 5005
