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Combination products, comprising a drug, device, and/or biologic, have emerged as innovative medical products whose impact will continue to grow in the coming years. Novel drug delivery devices, plus new and anticipated technologies, such as digital technology and energy activated drugs, are driving rapid change in the regulation and development of combination products and leading to rapid expansion of novel applications to better meet patient needs. Legal and regulatory developments have improved the framework for combination product development, approval, and lifecycle management but must continue evolving to keep pace with technological change.

The Combination Products Conference will examine the recent and ongoing changes in the regulatory ecosystem for combination product development and approval, including new FDA guidances, implementation status of PDUFA VI commitments around combination products, FDA collaborative decision-making models and the maturation of internal alignment at the agency, global regulatory changes, including the EU Medical Device Regulation implementation roadmap, and the direction of global alignment efforts. In-depth treatment of digital and eHealth issues, as well as complex generics and their impact on innovator product policy and business perspectives will be featured.

In an interactive format, relevant stakeholders from regulatory agencies and industry will present the challenges and opportunities in combination product development and lifecycle management. You will take away today’s best answers to these questions: How can the new legal and regulatory tools be used to best advance combination product development and approval? How can the regulatory framework for combination products be continuously improved? How can new technologies be leveraged to realize opportunities in development of new therapies to meet patient needs?

Short Course: How the MDR will Affect Combination Products

Gain an overview on how the new EU Medical Device Regulation approaches combination products combining medical devices and pharmaceuticals, in particular the differences to the current legislation and the additional challenges for manufacturers.

On-Demand Complimentary Webinar

Combination Products Postmarketing Safety Reporting: Overview, Challenges, Solutions
This webinar will provide an overview of the safety reporting requirements of the final rule and assess the areas that are likely to present the greatest compliance challenges. Real-world, least burdensome approaches to compliant postmarket safety reporting for US and globally marketed combination products will be discussed and industry best practices highlighted.

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NEW! Travel Once, Learn Twice!
This year DIA's Combination Products Conference will be co-located with DIA's Complex Drug-Device Generic Combination Products Meeting. Maximize your education and time by attending both! Save* $100 when you register for both events!
*You must register for both events at the same time for the discount to be applied.

Program Committee

  • Rachel SW Turow, JD, MPH
    Rachel SW Turow, JD, MPH Executive Counsel, Regulatory Law
    Teva Pharmaceuticals Ltd., United States
  • David  Amor
    David Amor Vice President, Quality and Regulatory
    Pear Therapeutics, United States
  • Ryan  McGowan
    Ryan McGowan Associate Director, Combination Products
    AstraZeneca, United States
  • Kirsten H. Paulson, MS, RAC
    Kirsten H. Paulson, MS, RAC Senior Director, Global CMC Medical Devices
    Pfizer Inc, United States
  • Nancy  Stade, JD
    Nancy Stade, JD Partner
    Sidley Austin LLP, United States
  • James  Wabby
    James Wabby Executive Director, Regulatory Affairs Devices and Combination Products
    Allergan, United States
  • John Barlow Weiner, JD
    John Barlow Weiner, JD Associate Director for Policy
    FDA, United States
  • Bill  Zeruld
    Bill Zeruld Business Development - Digital Strategy
    Otsuka America Pharmaceuticals, Inc., United States
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Short Course

How the MDR will Affect Combination Products

Co-located Meeting

Complex Drug-Device Generic Combination Products Meeting
*Save $100 when you register for both at the same time!

On-Demand Complimentary Webinar

Combination Products Postmarketing Safety Reporting: Overview, Challenges, Solutions

Digital Learning Catalog

DIA Learning: 2018 eLearning Soultions