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Welcome and Session 4: Ask the Regulator
Session Chair(s)
Emanuela Lacana, PHD
Deputy Director, OTBB, OND, CDER, FDA, United States
During this session regulators from around the world will provide updates on new initiatives, guidance and regulatory approaches pertinent to their jurisdiction. Following the presentations, panelists will address questions from the audience.
Learning Objective : At the conclusion of this session, participants should be able to:
- Define updated regulatory requirements discussed by the speakers
- Compare regulatory requirements across jurisdictions and identify commonalities and differences
- Discuss the impact of updates described by speakers on global biosimilar development programs
Speaker(s)
Patricia Aprea, MD
Director, Evaluation and Control of Biológicals/Research, ANMAT, Argentina
Speakers
Lu-Ning Cui, MD, PHD
Senior Clinical Evaluator, HPFB, Health Canada, Canada
Speaker
Hye-Na Kang, DVM
Scientist, Access To Medicines and Health Products, World Health Organization, Switzerland
Speaker
Emily Gebbia, JD
Associate Director for Regulatory Development, OC, OSI, CDER, FDA, United States
Speaker
Elena Wolff-Holz, MD, PHD
Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor, Paul-Ehrlich Institut, Germany
Speaker
Emanuela Lacana, PHD
Deputy Director, OTBB, OND, CDER, FDA, United States
Speaker
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