2018 PDA Biosimilars Workshop

Parenteral Drug Association Connecting People, Science and Regulation ^®

Agenda

2018 PDA Biosimilars Workshop Program Agenda

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Attendee List

2018 PDA Biosimilars Workshop: as of September 21, 2018

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Emanuela Lacana, PhD

P1: Regulatory Perspective on Biosimilar Marketing Applications

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Martijn van der Plas, PhD

P1: Regulatory Perspective on Biosimilar Marketing Applications

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Chantal Depatie, PhD

P1: Regulatory Perspective on Biosimilar Marketing Applications

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P1: Breakout

P1: Breakout

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P1 Breakouts Notes

P1: Breakout Notes

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Jee Chung, PhD

P2: The Trapeze and The Trap Door: Navigating High Level Technical Challenges in Biosimilar Development

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Catherine A. Srebalus Barnes, PhD

P2: The Trapeze and The Trap Door: Navigating High Level Technical Challenges in Biosimilar Development

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Daeseok Choi, PhD

P2: The Trapeze and The Trap Door: Navigating High Level Technical Challenges in Biosimilar Development

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P2: Breakout

P2: Breakout

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P2 Breakouts Notes

P2: Breakouts Notes

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Martijn van der Plas, PhD

P3: Demonstrating Analytical Similarity: The Role of Statistics Tools

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Richard K. Burdick, PhD

P3: Demonstrating Analytical Similarity: The Role of Statistics Tools

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Thomas Stangler

P3: Demonstrating Analytical Similarity: The Role of Statistics Tools

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P3: Breakout

P3: Breakout

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P3 Breakouts Notes

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Biosimilars IG Information

Biosimilars Interest Group Information

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Attendee Presentations