Presentations

Enhanced Delivery Options for Injectables

In this webinar, Baxter’s Kristie Zinselmeier and BD’s Brian Lynch present the challenges and opportunities of injectable administration, including:

• Global market trends
• Enhanced delivery case studies
• Market research
• Lifecycle management through collaboration

BIOSIMILARS: Global Terminology, Strategy & Pathways

Features Baxter's Kelly Davis, Regulatory Affairs, Associate Director, and outlines:

• Biosimilar definition
• US and Europe Regulatory Pathways
• Biologics Price Competition and Innovation Act
• 351(k) Application Requirements

Shoot for Share: From Vial to Prefilled Syringe

Features Baxter’s Raul Soikes, Sr. Director, Program Management, and provides insight on:

• Value proposition of moving to a prefilled syringe
• Regulatory planning to enable the move
• Process to move from vial (liquid or lyophilized) to syringe
• Qualifications of partners

Can’t Touch This! The Three W’s of Barrier Isolator Technology

Features Baxter’s Frank Generotzky, Director of Technology & Engineering, and Corinna Schneider, QA Specialist of GMP Compliance, and discusses:

• How Barrier Isolator Technology differs
• Strategies to use to validate the sterilization with vaporized hydrogen peroxide (VHP)
• How isolators makes sense from a quality and ROI perspective

Power Up Your Analytical Methods Transfer

Featuring Baxter’s Wendy Saffell-Clemmer, Manager, Pharmaceutical Research & Development, this webinar provides insight on:

• Critical elements of success
• Examples of transfer for biologics
• Regulatory guidance on method transfer and method validation