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TODAY : Advance Search
Oct 2016


Renaissance Washington, DC Dupont Circle Hotel 1143 New Hampshire Avenue NW Washington , District of Columbia 20037
Tel: (202) 775-0800
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DIA Biosimilars 2016 - Drug Information Association


Event Overview:

The 2016 conference will address biosimilars science, global regulatory pathways, evidence for clinical applications, and education for prescribers and patients.

The 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
    Patient Access

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

Exhibitor Information:

Reach Your Audience
At DIA conferences, medical product developers, regulators, academics, and patient advocates all come together in one place, eager to receive fresh insight and share new information. DIA conferences are the perfect place for you to communicate your key messages to an influential audience, efficiently and cost effectively.

The Biosimilars 2016 Meeting offers interested companies the opportunity to exhibit with a tabletop display.

We are also excited to offer additional marketing opportunities to reach conference participants, including a preconference eBlast to registered attendees, or email banner ad.

About DIA:

For more than 50 years, DIA (the Drug Information Association) has served as a global forum for all those involved in health care product development and life cycle management to exchange knowledge and collaborate in a neutral setting. DIA is an essential resource that provides opportunities to extend debate and discussion to advance scientific and medical innovation.





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