Learning Tracks

Ask a Regulator

1:15 p.m. - 2:30 p.m.

For this “Ask the Regulator” panel session, participants will have an opportunity to ask regulators from several countries any questions regarding biosimilar regulations in their respective countries. This panel will feature representatives from FDA (OTBB), Health Canada, and EMA.


Denis Arsenault, PhD
Manager, Policy Development, Health Canada

Fabricio Carneiro de Oliveira
General Manager, Medicines, APIs and Biological Products Office Chief, Brazilian Health Regulatory Agency (Anvisa)

Debashish Dutta
Senior Director & Head- Global Product Registrations & Regulatory Ops, Dr. Reddy’s Laboratories Ltd. (Biologics)

Maria Gutierrez-Lugo, PhD
Review Chief, Division of Biotechnology Review and Research III, OBP, OPQ, CDER, FDA

Peter Richardson, PhD
BMWP Scientific Secretary, European Medicines Agency

Sarah Yim, M.D.
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, FDA


Virginia Carroll, PhD
Senior Pharmaceutical Quality Assessor, DBM, OPMA, OPQ, CDER, FDA


Fabrice Romanet
Senior Vice President, Head of Program Leadership, Regulatory and Governmental Affairs, Fresenius Kabi Biopharma