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Session 7: Ask the Regulators
Session Chair(s)
Juliana Marguerite Reed, MS
Executive Director
The Biosimilars Forum, United States
Use this unique opportunity to share your pressing questions with the FDA and global regulatory and policy experts. Panelists will address questions posed live during the conference or submitted in advance to the DIA registration desk onsite. Questions may focus on information shared during the sessions, but may also branch out into other areas of biosimilars.
Speaker(s)
Speaker
Leah Christl, PhD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Speaker
Cathy A. Parker
Health Canada, Canada
Director General, Biologics & Genetic Therapies Directorate HPFB
Speaker
Jian Wang, MD, PhD
Health Canada, Canada
Division Manager, Clinical Review Division – Heamatology/Oncology
Speaker
Kyoko Sakurai, PharmD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of Cellular and Tissue-Based Products
Speaker
Leon van Aerts, PhD
Medicines Evaluation Board, The Netherlands, Netherlands
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