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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)
Leah Christl, PHD
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy, Amgen, United States
Panelist
Cathy A. Parker
Director General, Biologics & Genetic Therapies Directorate HPFB, Health Canada, Canada
Panelist
Jian Wang, MD, PHD
Division Manager, Clinical Review Division – Heamatology/Oncology, Health Canada, Canada
Panelist
Martina Weise, DrMed, MD
Head, Licensing Division 2, BfArM; German CHMP Alternate, Bfarm, Germany
Panelist
European Medicines Agency Speaker Invited
, European Medicines Agency, Netherlands
Panelist
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