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Assembling the BLA for your Biologic, Biosimilar , and Biobetter

Assembling the BLA for your Biologic, Biosimilar , and Biobetter. Suzanne M. Sensabaugh , MS, MBA IIR: Business of Biosimilars September 20, 2010. Workshop agenda. Contents of BLA submissions Assessing the risk of immunogenicity Pharmacovigilance plan Subsection (k) BLAs. Purpose .

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1.71k views • 112 slides

Drug Quality and Safety: Comparison of EMEA and FDA Rules

Drug Quality and Safety: Comparison of EMEA and FDA Rules. FDA Regulatory and Compliance Symposium: Managing Risks From Pipeline to Patient Cambridge, Massachusetts August 25, 2005 Linda R. Horton, Partner Hogan & Hartson L.L.P. - Brussels lrhorton@hhlaw.com. What we will discuss.

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799 views • 59 slides

Pharmaceutical Medical Writing

Pharmaceutical Medical Writing . Lorraine McMurdo, PhD Managing Director, Prescriptive Services Director, Pharmaceuticalethics.com lmcmurdo@preserv.co.uk Lorraine.McMurdo@pharmaceuticalethics.com.

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652 views • 42 slides

Request for Additional CTD Guidance

Request for Additional CTD Guidance. Structured approach to integrated clinical summaries/analyses and individual study reports

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380 views • 5 slides

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Common technical document - PowerPoint PPT Presentation

Assembling the BLA for your Biologic, Biosimilar , and Biobetter

Drug Quality and Safety: Comparison of EMEA and FDA Rules

Pharmaceutical Medical Writing

Request for Additional CTD Guidance