Description

Practical Challenges With Quality System Management

Practical Challenges with Quality System Management in Cell and Gene Therapies This session will focus on the challenges with the establishment of quality oversight and systems from the initial patient interface through manufacturing and supply for cell and gene therapies.  Experience with the application of cGMPs in the hospital setting will be discussed as well as the conflicting priorities when multiple companies are imposing different demands on the same institutions, notably as these controls are part of the approved applications. The efforts to harmonize standards globally, as well as the regulator experience in determining true compliance risks will be addressed.  

• FDA Perspective on GMPs for Cell & Gene Therapies
  Ekaterina Allen, PhD, RAC, Regulatory Project Manager & CMC Facilities Reviewer,
  FDA/CBER  
• Quality Considerations for Cell & Gene Therapy
  Luciana Mansolelli, Head Quality Strategic Planning, Cell & Gene Technical Development & Manufacturing
  Novartis
• Challenges for GMPs for ATMPs: European Perspective
  Lina Ertle, Head of External Relations EMEA &
  Japan, Roche

Moderator(s):

• Vivianne J. Arencibia, Independent Consultant, Arencibia Quality Compliance Associates

Speaker(s):

• Ekaterina Allen, PhD, Regulatory Project Manager and CMC Facilities Reviewer, CBER/FDA
• Luciana Mansolelli, Director, Operations & Strategic Planning, Novartis
• Lina Ertle, Head of External Relations EMEA and Japan, F. Hoffmann-La Roche Ltd.