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Renata Varga, Ph.D.
Sr. Scientist at Teva Pharmaceuticals

Profile

Renata Varga graduated as a Chemist working with solid phase peptide synthesis and enzymatic reactions. She obtained a PhD in Hungary in analytical chemistry by analyzing surface water samples for pharmaceutical residues with LC-MS/MS after solid phase extraction. She started to work in Teva Pharmaceuticals as a Research Analyst in the Sterile R&D, Godollo, Hungary. She has expertise in the development and NDA/ANDA regulatory filing of sterile infusions, injections, eye-drops, lyophilized powders and therapeutic peptides. She moved to CMC Biologics in West Chester, PA, where she was working as a Characterization Scientist, providing CQA Assessments for all peptides and monoclonal antibodies under development in Teva Pharmaceuticals, performed characterization studies for product variants, mainly size- and charge variants, and for higher-order structure and contributed to IND/BLA authoring. Currently she is the CMC Biosimilars Champion overseeing and providing strategic support for all biosimilar product development in Teva Pharmaceuticals, collaborating with non-clinical, clinical, regulatory and commercial groups, on top of serving as the analytical lead for two of the biosimilar projects.

Agenda Sessions

  • Regulations For Interchangeability Studies for Biosimilars

    11:40am