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Hyatt Regency Bethesda

Sep 28, 2015 7:30 AM - Sep 29, 2015 4:30 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Drug and Device Combination Products 2015: Navigating Regulation, Enhancing Collaboration, and Accelerating Development

Engage with key regulators and partners in practical approaches to navigate regulatory requirements, enhance collaboration and accelerate combination product development.


Advances in scientific knowledge and technology are driving growth and innovation for “combination products” - therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. This innovation continues to blur the historical lines separating traditional drugs, biologics, and medical devices. The regulatory landscape is dynamic and the development and marketing authorization pathways for combination products raise unique challenges when compared to drugs, devices, or biological products alone.  These differences impact many aspects of product life cycle management, including pre-clinical and clinical evaluation, regulatory approval processes, manufacturing and quality controls, post-market surveillance, adverse event reporting, promotion and advertising, and post-approval modifications.

This conference will provide practical approaches and up-to-date information for combination product development processes and regulatory requirements.  The two-day conference will include:

  • Updates from FDA and other regulators
  • Combination product cGMP requirements and practical approaches
  • Current “hot” topics in marketing applications
  • Collaboration with various partners in developing combination products
  • Interactive case studies to enhance learning

Featured topics

  • cGMP Guidance
  • Regulatory Updates
  • Human Factors


Want to learn more about Drug and Device Combination Products 2015: Navigating Regulation, Enhancing Collaboration, and Accelerating Development? You've come to the right site!


Who should attend?

Professionals involved with:

  • Drug and Device Development and R&D Professionals
  • Pharmaceutical and Medical Device Professionals
  • CMC and Other Professionals Responsible for Developing Drug/Device Combination Products
  • Regulatory Affairs Professionals
  • Quality Professionals
  • Business Development Professionals

Learning objectives

At the conclusion of this activity, participants should be able to:

  • Describe the US regulatory framework for drug/device combination products
  • Identify Current Good Manufacturing Practice requirements of combination products
  • Discuss effective collaboration techniques to develop combination products with various partners
  • Recognize current issues facing combination product manufacturers and describe potential approaches to address these challenges
  • Describe the current status of combination products including the emerging issues in the EU and other regions

Program Committee

  • John  Weiner, JD
    John Weiner, JD Associate Director for Policy, Office of Combination Products, OCPP, OC
    FDA, United States
  • Winifred  Wu, MBA
    Winifred Wu, MBA President and Principal Advisor
    Strategic Regulatory Partners, LLC, United States
  • Steven B. Binion
    Steven B. Binion Director, Policy, Technology, and Communication - Corporate Regulatory Affairs
    Becton Dickinson, United States
  • James A. Boiani, JD, MS
    James A. Boiani, JD, MS Partner
    Epstein Becker & Green, P.C., United States
  • Jon  Cammack, PhD
    Jon Cammack, PhD Vice President, R&D/Clinical Quality
    AstraZeneca, United States
  • Kirsten H. Paulson, MS, RAC
    Kirsten H. Paulson, MS, RAC
    Pfizer, Inc., United States

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