Global Regulatory Sessions

• 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.

Registration Rates

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