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Global Regulatory Sessions

Regulatory Affairs Around the World: Map Your Sessions at DIA 2018

  • Monday, June 25

    Analyzing Innovations Progress in the Gottlieb Era

    11:00AM-12:30PM

    This DIAmond Session will bring together top regulatory thought leaders from FDA, industry, and the venture capital world, for an interactive, forward-looking discussion of FDA’s modernization plan and its impact on development of innovative therapies.

    International Regulatory Convergence

    3:00-4:30PM

    Join senior leadership from international regulatory agencies to hear the latest on multi and bilateral initiatives to avoid duplication and increase mutual reliance, strategic governance, and their impact on industry.

    FDA Expectations for Demonstration of Interchangeability

    3:00-4:00PM

    This session will detail our current understanding of FDA expectations for demonstration of interchangeability of a biological product with a reference product with regards to study designs, duration of switches, PK/PD immunogenicity sampling, statistical analysis, and product presentation considerations.

    TFDA Town Hall

    3:00-4:15PM

    TFDA will share the updated information of regulatory management of drug development, challenges of MRCT implementation, the application of real world evidence, and innovative biotechnological medicine.

  • Tuesday, June 26

    FDA Data Standards Update

    8:00-9:15AM

    FDA's Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will implement a joint data standards strategy, with supporting action plan. In this session, FDA will present their joint strategy, action plan, and updates.

    Global Perspectives on Patient Engagement

    10:30AM-12:00PM

    A diverse panel representing regulators, patient groups, and industry from regions such as Asia and Latin America will talk about current experience, hopes, and aspirations for patient engagement worldwide.

    Generic Drug Town Hall

    10:30-11:45AM

    A panel of senior FDA staff will share information related to the implementation, policy, and regulatory science updates related to the Generic Drug User Fee Amendments (GDUFA).

    Regulators’ Utilization of Real-World Data in Pharmacovigilance Activities

    10:30-11:30AM

    During this session, FDA, PMDA, and Health Canada will discuss the challenges faced in exploring new methods and designing and conducting these studies, and future areas of research, including opportunities for international collaborative research.

  • Wednesday, June 27

    Global Rare Disease Town Hall

    8:00-9:15AM

    Join FDA in this forum that will address the unique regulatory complexities and challenges specific to orphan drug development.

    PMDA Town Hall

    2:00-3:15PM

    PMDA will share its activities to promote high-quality, innovative medical research and clinical trials meeting or exceeding international standards, as well as its advocacy for the application of “Big Data” in medical practice.

    Update on BREXIT

    4:00-5:00PM

    Gain an overview of the current state of play of the political process from a UK as well as an EU perspective.

  • Thursday, June 28

    EMA/FDA Question Time

    9:00-10:30AM

    EMA and FDA leadership come together at a round table discussion on areas covered by the EMA/FDA confidentiality arrangements and how both agencies contribute to global development and supervision of medicines. Attendees are encouraged to come prepared with questions for the EMA/FDA Question Time panel.

    FDA Town Hall

    10:45AM-12:00PM

    This forum will include discussions and updates from FDA leadership on regulatory issues and the audience will be invited to submit questions of general interest.


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