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Event NameDIA Biosimilars 2016
Event Date(s) Thursday, October 27, 2016  to Friday, October 28, 2016
Event Location Renaissance Washington DC Dupont Circle Hotel
Washington, District of Columbia
Cost$675 - $1,900
DescriptionThe development of biosimilars is increasing at a rapid pace in all global regions, including the US with FDA’s approval of multiple biosimilars. With their potential for improving access to effective biological therapies through reduced costs, biosimilars have garnered great interest among industry, regulators, and payers. Biosimilars 2016 will address issues around biosimilars science, global regulatory pathways, evidence for clinical applications, and education for prescribers and patients that are key to successful uptake of these products.

Featured topics

• Global Regulatory Updates
• Totality of the Evidence
• Clinical relevance of critical quality attributes (CQA)
• Challenges of Generating Clinical Data
• Real-World Evidence: Post-Approval
• Interchangeability and Switching
• Education
• Patient Access

Who should attend?

Professionals who are 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

Learning objectives

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

• Describe how the totality of evidence, including CMC, in vitro, nonclinical, and clinical data, can be amalgamated to demonstrate biosimilarity and meet regulatory expectations for approval of biosimilar applications
• Discuss the concept of the clinical relevance of critical quality attributes and the assessment of their impact on potency, PK, immunogenicity, and safety
• Explain the extent to which critical quality attributes need to align with the reference product and the application of statistical approaches that will meet regulatory requirements for acceptance of biosimilarity
• Discuss the challenges in generating the requisite clinical data to confirm biosimilarity and considerations for designing a successful biosimilar clinical trials program to meet global requirements
• Examine the impact of adoption of biosimilars and (potentially) interchangeable biologics by prescribers and health care professionals on their introduction to patients
• Outline the need and potential approaches for education on the concept and value of biosimilars
Host CompanyN/A
Contact Information Phone: 1-215-442-6100
Fax:   215-442-6199 
More Information