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Hyatt Regency Bethesda

2015 年 10 月 19 日 7:00 上午 - 2015 年 10 月 20 日 4:30 下午

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Biosimilars 2015

Interact with FDA and international agencies to discuss the latest updates and outlooks for biosimilar regulation, while examining the potential implications for patients and HCPs.

概览

Tutorial:  October 18*
Meeting:  October 19-20

*Tutorials require registration and are an additional fee


With the approval of the first biosimilars in the US and potentially more to follow, and with expiration of patents for originator biologicals, the market for biosimilars is poised to grow at a rapid pace. These biosimilars and follow-on biologics have garnered great interest presenting new market opportunities for industry and potential for cost-effective benefits in patient care.

As biosimilars become more available to patients, there are important factors for patients and health care providers that must be addressed. This meeting will focus on the innovations, technologies, and regulatory information surrounding biosimilars. This is an exciting time in our industry.  DIA’s Biosimilars 2015 is the ideal time to hear from FDA and international agencies – What will they expect in biosimilars going forward?

This two-day interactive meeting will include topics on:

  • US and Global Regulatory Developments
  • US and Global Commercial Considerations
  • Biosimilars in the US
  • Quality Considerations
  • Clinical Considerations
  • Biosimilars in Oncology
  • Interchangeability
  • The Payer Perspective
  • And More

Featured

Want to learn more about Biosimilars 2015? You've come to the right site!

Continuing-Education

谁应该参加?

Professionals involved in:

  • Pharmaceutical Executives
  • Biomedical Product Developers
  • Regulatory Affairs Professionals
  • Clinical and Nonclinical Researchers
  • Biostatisticians and Data Managers
  • Business Development Executives
  • Marketing and Commercialization staff involved with biosimilars
  • Physicians
  • Oncologists

学习目标

At the conclusion of this activity, participants should be able to:

  • Identify the unique challenges and complexities associated with demonstrating biosimilarity to a reference product
  • Examine the implications for patients and healthcare professionals as biosimilars and (potentially) interchangeable biologics are introduced into the market

Short Course or Primer

To keep you at the forefront.

2015 年 10 月 18 日

Tutorial:

Achieving Biosimilarity Through Matching of Critical Quality Attributes to Reference Products

项目委员会

  • Cecil J. Nick, MS
    Cecil J. Nick, MS FTOPRA, Vice President (Technical)
    Parexel Consulting, United Kingdom
  • Stan  Bukofzer, MD
    Stan Bukofzer, MD Corporate Vice President and Chief Medical Officer
    Hospira, Inc., United States
  • David  Gaugh, RPh
    David Gaugh, RPh Senior Vice President for Sciences and Regulatory Affairs
    Generic Pharmaceutical Association (GPhA), United States
  • Sundar  Ramanan, PhD
    Sundar Ramanan, PhD Director, Global Biosimilars R&D Policy
    Amgen Inc., United States
  • Julie Ann Rosenberg, MD
    Julie Ann Rosenberg, MD Development Asset Lead, Oncology Biosimilars, Pfizer Essential Health
    Pfizer, Inc., United States
  • Jian  Wang, MD, PhD
    Jian Wang, MD, PhD Division Manager, Clinical Review Division – Heamatology/Oncology
    Health Canada, Canada
  • Joerg  Windisch, PhD
    Joerg Windisch, PhD Chief Science Officer
    Sandoz Biopharmaceuticals, Austria
  • Leah  Christl, PhD
    Leah Christl, PhD Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
    Amgen, United States

Digital Learning Catalog

DIA Learning: eLearning Soultions
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