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DoubleTree by Hilton Grand Biscayne Bay

Feb 21, 2019 7:00 AM - Feb 22, 2019 5:00 PM

1717 N Bayshore Drive, Miami, FL 33132

Latin America Regulatory Conference

Join global regulators, industry, and academia to engage in a series of strategic discussions on current regulatory landscape, globalization, and harmonization initiatives in Latin America.

Session 5:Regulatory Update in Approving Biosimilars and Approach to Interchangeability

Session Chair(s)

Lisa  Ruiz

Lisa Ruiz

Senior Director,Latin America Area Head, Regulatory International

Abbvie, United States

Sonia  Viejobueno, LLM

Sonia Viejobueno, LLM

Associate Director, Regulatory Policy LATAM

Johnson & Johnson Innovative Medicine, Argentina

This session will be a regulatory update of the current trends in approving biosimilars. The US FDA, Anvisa, and Cofepris will discuss their recent regulations, expectations, and experiences approving biosimilars and their approach to interchangeability, understanding the particular challenges in their environment.

Speaker(s)

Daniela  Marreco Cerqueira, MS

Regulatory update in APPROVING biosimilars AND APPROACH TO INTERCHANGEABILITY

Daniela Marreco Cerqueira, MS

ANVISA, Brazil

Associate Director, Third Directorate

Cesar  Miglioranzza

IFPMA Policy Position

Cesar Miglioranzza

Novo Nordisk, Brazil

Regulatory Affairs Manager - LATAM

Leah  Christl, PhD

Considerations in Demonstrating Interchangeability With a Reference Product – FDA Draft Guidance for Industry

Leah Christl, PhD

Amgen, United States

Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy

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