返回 Agenda
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)
Speakers
Patricia Aprea, MD
ANMAT, Argentina
Director, Evaluation and Control of Biológicals/Research
Speaker
Lu-Ning Cui, MD, PhD
Health Canada, Canada
Senior Clinical Evaluator, HPFB
Speaker
Hye-Na Kang, DVM
Access To Medicines and Health Products, World Health Organization, Switzerland
Scientist
Speaker
Emily Gebbia, JD
FDA, United States
Associate Director for Regulatory Development, OSI, OC, CDER
Speaker
Elena Wolff-Holz, MD, PhD
Paul-Ehrlich Institut, Germany
Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor
Speaker
Emanuela Lacana, PhD
FDA, United States
Deputy Director, OTBB, OND, CDER