2017 Biosimilars

Parenteral Drug Association Connecting People, Science and Regulation ^®

Program Agenda

(?)
Deborah Baly, PhD

P6: Control Strategies for Biosimilars

(?)
Laurent Chevalet, PhD

P2: Strategies for Reverse Engineering

(?)
Niklas Ekman, PhD

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

(?)
Maria-Teresa Gutierrez Lugo, PhD

P6: Control Strategy for Biosimilars

(?)
Kate Hutterer, PhD

P8: Closing Plenary: Data Quality Expectations in Biosimilar Development

(?)
Kyung-Ah Kim, PhD

P6: Control Strategy for Biosimilars

(?)
Steven Kozlowski, MD

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

(?)
Monika Lang-Salchner, PhD

P5: Post-Marketing Change Management

(?)
Helmut Lerch, PhD

P7: Product Specifications for Biosimilars

(?)
Patrick J. Lynch, PhD

P3: Expectations and Practical Considerations for Analytical Similarity: Industry Case Studies

(?)
Alla Polozova, PhD

Presentation Not Authorized for Distribution

(?)
Leslie Rivera-Rosado, PhD

P7: Product Specifications for Biosimilars

(?)
Jens Schletter, PhD

P3: Expectations and Practical Considerations for Analytical Similarity: Industry Case Studies

(?)
Birgit Schmauser, PhD

P5: Post-Marketing Change Management

(?)
Emily Shacter, PhD

P4: Expectations and Practical Considerations for Analytical Similarity: Panel Discussion

(?)
Joel T. Welch, PhD

P8: Closing Plenary: Data Quality Expectations in Biosimilar Development

(?)
Jeff Yant, PhD

P3: Expectations and Practical Considerations for Analytical Similarity: Industry Case Studies

(?)

Attendee Presentations