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The pandemic has brought about an expectation of increased speed to deliver new medicines to patients, while the boundaries of science are being extended to deliver life-changing drugs to treat, prevent, modify, and even cure diseases. For example, ATMPS (Advanced Therapy Medicinal Products), MIDD (Model-Informed Drug Development) and advanced manufacturing technologies are being utilized for the next generation of medicines. However, more can be achieved through continual improvement.
Variations on regulatory assessments for the same drug create challenges to maintain the dossier throughout the lifecycle of the product and to implement post-approval changes that help prevent potential drug shortages. A collaborative effort to understand the degree of divergence and impact is an important step toward improved global harmonization of control strategies.
The ISPE Global Regulatory Town Hall will provide a forum to initiate a dialog between industry and regulators with the goal to formulate sustainable solutions.
Session Leader(s):
Mark
O'Connor,
Technical Lead and Production Start-up Manager,
AstraZeneca
Ciby
Abraham,
PhD,
Senior Director and Group Manager, Project and Product Leadership,
AstraZeneca
Connie
Langer,
Director, CMC - Global Regulatory,
Pfizer
Speaker(s):
Sau (Larry)
Lee,
PhD,
Deputy Director of Science Chair, Emerging Technology Program,
Office of Pharmaceutical Quality/CDER/FDA
Peter
Marks,
MD, PhD,
Director, Center for Biologics Evaluation and Research,
CBER/FDA
Mr. Hugo
Hamel,
MSc, MBA,
Manager, Biotherapeutic Quality Division,
Health Canada
Blanka
Hirschlerová,
Head of Department of Pharmaceutical Assessment,
State Institute for Drug Control
David
Churchward,
Global Head Sterility Assurance, Cell and Gene Technologies,
Lonza Biologics
Nélio
Cézar de Aquino,
Manager of National QC Laboratories Dept (GELAS/Anvisa),
National Health Surveillance Agency - ANVISA
Shinichi
Okudaira,
Deputy Review Director, Office of Cellular and Tissue-based Products,
Pharmaceuticals and Medical Devices Agency (PMDA)