Management of Vendors Providing Pharmacovigilance and Clinical Trial Services to the Pharmaceutical Industry
This Seminar will provide information key to managing a successful partnership with Vendors who provide essential services in ensuring that patient safety and data integrity are of an acceptable quality and comply with applicable GCP and GVP regulations. Case studies and various scenarios will also be provided with open interactive discussion opportunities encouraged.
By end of the Seminar attendees should be able to:
- Perform relevant risk assessment to identify and select appropriate (GCP and PV) Vendors
- Assess the requirements that Vendors should satisfy to fulfill their contractual obligations
- Monitor the performance of Vendors
- Understand the role of QA in supporting Vendor management (pre and post qualification activities)
- Analyze information (audit and inspections outcomes) to mitigate potential risks when working with Vendors
Staff from the following departments involved in working with Vendors:
- Clinical Operations
- Pharmacovigilance
- QA
- Project Management
- Vendor/Out-Sourcing