Patent and IP Overview for Drugs and Biologics: Understanding The Connection Between FDA Regulation and IP and Related Mechanisms Under Hatch-Waxman and BPCIA
March 12, 2014 • 1:45 pm
Understanding the Clinical Trial Process for Drugs and Biologics
March 12, 2014 • 11:30 am
The Nature of the Approval Process
March 12, 2014 • 10:15 am
Post-Approval Marketing Guidance and Preemption Protocols
March 13, 2014 • 1:15 pm
Co-Chairs’ Opening Remarks
March 12, 2014 • 8:30 am
Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics
The Basics: Understanding and Working with the FDA — Jurisdiction, Organization, and Operations
March 12, 2014 • 8:45 am
Recall Guidance for Drugs, Biologics, and Medical Devices: What You Need to Know
March 13, 2014 • 10:15 am
Adverse Events Monitoring, Pharmacovigilance and Risk Management
March 13, 2014 • 11:15 am
Medical Devices: Classifications, the Essentials of the Premarket Review Process, and Post-Market Requirements and Concerns
March 13, 2014 • 9:00 am
Drugs and Biologics: Labeling
March 12, 2014 • 4:00 pm
March 12, 2014 • 3:00 pm
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