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Session 7: Ask the Regulators
Session Chair(s)
Jian Wang, MD, PhD
Division Manager, Clinical Review Division – Heamatology/Oncology
Health Canada, Canada
Use this unique opportunity to share your pressing questions for the FDA and global regulatory agencies during the panel discussion.
You may submit a written question at anytime during the conference to the DIA registration desk. You can also present your question live at the session. Questions may focus on the various sessions, but may also branch out into other areas of biosimilars.
Speaker(s)
Panelist
Leah Christl, PhD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Panelist
Cathy A. Parker
Health Canada, Canada
Director General, Biologics & Genetic Therapies Directorate HPFB
Panelist
Jian Wang, MD, PhD
Health Canada, Canada
Division Manager, Clinical Review Division – Heamatology/Oncology
Panelist
Martina Weise, DrMed, MD
Bfarm, Germany
Head, Licensing Division 2, BfArM; German CHMP Alternate
Panelist
European Medicines Agency Speaker Invited
European Medicines Agency, Netherlands