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Combination Products Conference: Innovation and New Frontiers

October 24: Short Course*
October 25-26: Conference

Short Course: Combination Product Advanced Case Studies

*Short Courses require separate registration.

Combination products, comprising a drug, device, and/or biologic, are rapidly becoming the “next frontier” for innovative therapies. Novel drug delivery devices, plus new and anticipated technologies, such as digital and nanotechnology, 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. At the same time, recent legal and regulatory developments have improved the framework for development, approval, and life cycle management of combination products. 
The Combination Products Conference: Innovation and New Frontiers will examine the current regulatory ecosystem for combination product development and approval, including provisions of the 21st Century Cures Act, proposed PDUFA VI commitments, the implementation of new decision-making models at FDA, US regulatory developments, global regulatory changes, and global alignment efforts. In-depth treatment of digital and eHealth issues, labeling for combination products and complex generics, and CGMPs for combination products will be featured.

In an interactive format, relevant stakeholders from FDA and industry will present the challenges and opportunities in combination product development and life cycle management. Participants 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? Is the regulatory framework for combination products good enough and how can it be further improved? How can new technologies be leveraged to realize opportunities in development of new therapies to meet patient needs?

Approved by the Regulatory Affairs Professionals Society for 12 RAC credits.

Check out our program from 2016 here!

Program Committee

  • Rachel SW Turow, JD, MPH
    Rachel SW Turow, JD, MPH Executive Counsel, Regulatory Law
    Teva Pharmaceuticals Ltd., United States
  • Nathan  Brown, JD
    Nathan Brown, JD Health Care and Life Sciences Partner
    Akin Gump Strauss Hauer & Feld LLP, United States
  • Carla  Cartwright, JD, LLM
    Carla Cartwright, JD, LLM Director, Government Affairs and Policy, Federal Affairs
    Johnson & Johnson, United States
  • Kirsten H. Paulson, MS, RAC
    Kirsten H. Paulson, MS, RAC Senior Director, Global CMC Medical Devices
    Pfizer Inc, United States
  • Kim M. Quaintance-Lunn
    Kim M. Quaintance-Lunn Vice President and Head, US Regulatory Policy
    Bayer, United States
  • John Barlow Weiner, JD
    John Barlow Weiner, JD Associate Director, Policy and Product Classification Officer, OCP, OC
    FDA, United States
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Short Course 1

Combination Product Advanced Case Studies

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