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Bethesda North Marriott Hotel and Conference Center

Oct 29, 2019 7:15 AM - Oct 30, 2019 4:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Combination Products Conference

Where regulators and industry share insights on leveraging regulatory and technological change to advance combination products.


Short Course: October 28
Conference: October 29-30

Combination products, comprising a drug, generic, or biologic and a device, have emerged as innovative medical products whose impact will continue to grow in the coming years. The convergence of innovative medicines such as advanced cell and molecular biological products (Advanced Therapeutic Medicinal Products or ATMPs), materials science advances, and the development of digital therapies and applications is driving a rapid expansion of novel applications to better meet patient needs. Though substantial legal and regulatory developments in the past two to three years have improved the framework for combination product development, regulatory policies and processes will continue to evolve with the technology. Fundamentals such as quality systems and lifecycle management programs are evolving as well.

DIA's Combination Products Conference will examine the current US and global regulatory environments for combination product development and approval, including new FDA regulation and guidances, and late-breaking information on implementation of the EU Medical Device Regulation. Unique aspects of combination product development and lifecycle management that drive ongoing regulatory change will be explored, with a close look at the impact of CATMPs, generic combination products, and co-development of digitally connected combination products such as drug companion apps and digital monotherapies. Best practices for approaching regulators with novel product ideas and for obtaining Agency feedback on regulatory issues will be discussed with regulators in an interactive format.

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?

Need approval in order to attend?

Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.

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Continuing Education

Highlights & Features

Who should attend?

Senior Level Professionals and Decision-makers involved in:

  • Biopharmaceutical, Generics, Biosimilars, Device, and Combination Product R&D and Development
  • Business Development
  • Policy
  • Clinical Research
  • Consulting
  • Legal, Government Affairs
  • CMC
  • Quality Assurance and Control
  • eClinical
  • Regulatory Affairs, Regulatory Operations
  • Research and Development
  • Submissions

Learning objectives

At the conclusion of this activity, participants should be able to:
  • Interrelate pharmaceutical development practices to demonstrate design control compliance
  • Discuss recent regulatory changes and guidance in the areas of emerging technologies and best practices for approaching regulators with novel combination product ideas
  • Describe key clinical study design considerations for connected combination products including unique endpoints and instrumenting for RWE collection
  • Describe challenges and opportunities in lifecycle management programs for complex Combination Advanced Therapeutic Medical Products (CATMPs)

Short Course or Primer

To keep you at the forefront.

Oct 28, 2019

Short Course:

How Much is Enough? Best Practices and Principles for the Non-Lead Constituent Part Within a Regulatory Submission for a Combination Product

Program Committee

  • James  Wabby, MHS
    James Wabby, MHS Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
    AbbVie, United States
  • David  Amor
    David Amor Digital Health - QA/RA
    Apple, United States
  • Ryan  McGowan
    Ryan McGowan Associate Director, Combination Products
    AstraZeneca, United States
  • Kirsten H. Paulson, MS, RAC
    Kirsten H. Paulson, MS, RAC
    Pfizer, Inc., United States
  • Rachel  Turow, JD, MPH
    Rachel Turow, JD, MPH Managing Counsel, FDA Regulatory
    Walmart, Inc., United States
  • John  Weiner, JD
    John Weiner, JD Associate Director for Policy, Office of Combination Products, OCPP, OC
    FDA, United States
  • Bill  Zeruld
    Bill Zeruld Business Development - Digital Strategy
    Otsuka America Pharmaceuticals, Inc., United States

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