PDA Biosimilars Conference

Lisa Carlson

P6: Control Strategy for Biosimilars (with Case Studies)

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John Geigert, PhD

Breakfast Session: CMC Considerations for Global Registrations

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Jose Gomes

(NEW) P4: Additional Practical Considerations for Analytical Similarity (Case Studies)

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Laurie Graham, PhD

(NEW) P6: Control Strategy for Biosimilars (with Case Studies)

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Maria-Teresa Gutierrez-Lugo, PhD

(NEW) P7: Product Specifications for Biosimilars

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Alan Herman, PhD

P3: Demonstrating Analytical Similarity (with case studies)

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Christopher Holloway, PhD

P1: Opening Plenary Session: Current Agency Expectations for Approval for Biosimilars

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Christopher Holloway, PhD

P5: Post Marketing Change Management

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Margaret Karow, PhD

P2: Establishing QTPP for Biosimilars (Case Studies)

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Steven Kozlowski, MD

(NEW) P1: Opening Plenary Session: Current Agency Expectations for Approval for Biosimilars

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Stephan Krause, PhD

(UPDATED) P8: Closing Plenary: Other Practical Considerations for Biosimilars (Case Studies)

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Mark McCamish, MD, PhD

P5: Post Marketing Change Management

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Emily Shacter, PhD

(UPDATED) P7: Product Specifications for Biosimilars

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Marjorie Shapiro, PhD

P3: Demonstrating Analytical Similarity (with case studies)

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Corinna Sonderegger, PhD

(UPDATED) P2: Establishing QTPP for Biosimilars (Case Studies)

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Corinna Sonderegger, PhD

P8: Closing Plenary - Other Practical Considerations for Biosimilars (Case Studies)

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Harry Yang, PhD

P4: Additional Practical Considerations for Analytical Similarity (Case Studies)

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