A BioPhorum member only survey gathering feedback on initial submission Biologics License Applications (BLA) / Marketing Authorization Application (MAA) supplement/variation, etc.) and the outcome of health authority review and approval of the submission.
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The interplay, engagement and interactions between Sponsor and C(D)MO are frequently considered, presented and discussed at the BioPhorum Development Group, a gathering of more than 20 global biopharmaceutical companies, representing both Sponsor and C(D)MO organizations, with a focus on chemistry, manufacturing and controls (CMC)-related clinical biopharmaceutical development, testing and manufacture. This self-survey was aimed at understanding outsourcing approaches and governance and focused on analytical development and testing, process development and manufacturing, project management and governance and quality system and regulatory support. From the aggregate survey responses in each area, key trends were identified, providing insights to potential best practices