Drug Information Association Logo
Corporate Tagline

Session 2A: Round-table: Biosimilar Trials: Clinical and Regulatory Issues

Day & Time:
October 21, 4:20PM - 5:50PM

Type:
Session

Title:
Session 2A: Round-table: Biosimilar Trials: Clinical and Regulatory Issues

Chair(s):
Daniel Mazzolenis, MD
Sr Medical Director, Global Oncology Hematology
INC Research, Argentina

Octavio Nunes
Communications Director
Pharmacuetical Research Industry Association, Brazil

Description:
To present the audience with a panorama of main developments in the biosimilars space and how they impact clinical trials in Latin America. The speakers will be presenting different perspectives on clinical trial designs for biosimilars: local LatAm regulatory, industry and the FDA regulatory's point of view.

Presentation(s) & Speaker(s):
Ines Bignone, MD
Department of Medicine Evaluation
ANMAT, Argentina

FDA Regulatory Perspective **FDA participation contingent on U.S. Government ending operations shutdown
Leah Christl, PhD
Associate Director for Therapeutic Biologics, OMBT, OND, CDER
FDA, United States

Brazilian Regulatory Perspective
Alessandro Ferreira do Nascimento, MD
Clinical Research Coordination Expert
Brazilian Health Surveillance Agency (ANVISA), Brazil

Clinical Trial Designs Issues for Biosimilars Development
Valdair Pinto, MD
Independent Consultant
Brazil