Lunchtime Workshops

Workshop A: Advancing Your R&D Category Management

13.15 – 14.15
Tuesday, August 4

At this lunch time deep dive, you will explore how this key procurement toolbox has evolved to adapt to change. In this end-user led interactive session, Gerard and Rinaldo
will leverage their own category management experience, spanning over 15 years specifically within pharma/biotech,
to discuss:

• Smart category design when many vendors cut across a multitude of services
• Delve deeper into individual categories to refine your strategic sourcing strategy
• How to effectively involve category management in supplier selection

Workshop Leaders:

Gerard Cardillo CR Labs

Gerard Cardillo
Executive Director
Charles River Labs

Rinaldo Doorman Cerevel

Rinaldo Dorman
Procurement Lead
Cerevel

Workshop B: Regulatory Expectation for Vendor Oversight

12.00 – 13.00
Wednesday, August 5

This interactive deep dive aims to provide you with a robust and actionable understanding of the growing regulatory expectations for Pharma and Biotech companies to establish consistent, documented processes for operational
oversight of their outsourced R&D activities across GxPs.

Through the presentation of information and real-world examples, as well as interactive discussion, you will learn:

• Why global regulators are highly focused on vendor oversight now and their expectations
• Why consistent, ongoing, operational vendor oversight is critical to patient safety
• Why vendor qualification and QA audits are not synonymous with operational oversight
• Establishing a GxP-wide company policy and governance for vendor oversight
• Developing and documenting practical operational oversight processes
• What types of documentation will satisfy global regulators during inspections; how can companies
• Properly document vendor oversight?

Workshop Leader:

Penelope Przekop

Penelope Przekop
CEO
PDC Pharma Strategy