Overcoming Global Regulatory Misalignment to Increase Efficiency in Viral Vector Manufacturing

• Clarifying definitions of raw materials, starting materials, and ancillary components to enable global alignment and consistent quality expectations
• Discussing how industry and regulators can collaborate through pharmacopeial channels to anticipate evolving expectations
• Highlighting gaps and inconsistencies across regional guidance and how standardsetting organizations can help bridge interpretation differences

Speakers:

Brett Howard

Senior Director

U.S. Pharmacopeia