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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)
Leah Christl, PhD
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy, Amgen, United States
Speaker
Cathy A. Parker
Director General, Biologics & Genetic Therapies Directorate HPFB, Health Canada, Canada
Speaker
Jian Wang, MD, PhD
Division Manager, Clinical Review Division – Heamatology/Oncology, Health Canada, Canada
Speaker
Kyoko Sakurai, PharmD
Reviewer, Office of Cellular and Tissue-Based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker
Leon van Aerts, PhD
, Medicines Evaluation Board, The Netherlands, Netherlands
Speaker
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