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Renaissance Washington DC Dupont Circle Hotel

Oct 27, 2016 8:15 AM - Oct 28, 2016 5:00 PM

Formerly Renaissance M Street Hotel, 1143 New Hampshire Avenue, NW, , Washington, DC 20037 , USA

Biosimilars 2016

Preview the New Agenda for DIA Biosimilars 2016, the Premier Global Biosimilars Conference.

Session 6: Global Harmonization and Regulator Update

Session Chair(s)

Jian  Wang, MD, PhD

Jian Wang, MD, PhD

Division Manager, Clinical Review Division – Heamatology/Oncology

Health Canada, Canada

Biosimilars developed for launch in multiple regions require a planned and focused strategy, involving the selection of the suitable reference product(s), defining the extent of comparative process and product characterization, and design of nonclinical and clinical studies to meet regulatory requirements. A clear and concise understanding of the regulatory framework of major regions and regulatory convergence activity among regions would be desirable for a good business strategy. This session will bring together regulatory authorities to discuss current regulatory evolution and convergence for biosimilars in the various global locations.

Speaker(s)

Leah  Christl, PhD

FDA Update

Leah Christl, PhD

Amgen, United States

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

Cathy A. Parker

Health Canada Update

Cathy A. Parker

Health Canada, Canada

Director General, Biologics & Genetic Therapies Directorate HPFB

Martina  Weise, DrMed, MD

CHMP Update

Martina Weise, DrMed, MD

Bfarm, Germany

Head, Licensing Division 2, BfArM; German CHMP Alternate

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