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Bethesda North Marriott Hotel and Conference Center

Oct 25, 2017 7:00 AM - Oct 26, 2017 3:30 PM

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

Combination Products Conference

Innovation and New Frontiers

Overview

October 24: Short Course: Combination Product Advanced Case Studies
*Lunch not included with Short Course.
October 25-26: Conference

The DIA 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.

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Continuing-Education

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Exhibits

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Who should attend?

Professionals involved in:

  • Biopharmaceutical, Device, and Combination Product R&D and Development
  • Regulatory Affairs
  • Policy
  • Clinical Research
  • Consulting, Legal, Government Affairs
  • CMC
  • Quality assurance and Control
  • Business Development

Learning objectives

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

  • Examine recently issued guidelines and regulations, including FDA’s latest implementation efforts for 21st Century Cures in the combination product space
  • Discuss the FDA final guidance for combination product GMPs and identify appropriate mechanisms for resolving GMP-related questions for combination products
  • Describe the challenges associated with global registration of combination products and regulatory strategies for navigating differing requirements in different countries
  • Explain recent regulatory changes for digital health products and their impact on digital health drug/device combination products
  • Identify challenges associated with establishing bioequivalence for generic products, as well as for combination products

Short Course or Primer

To keep you at the forefront.

Oct 24, 2017

Course:

Combination Product Advanced Case Studies

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Program Committee

  • Rachel Turow, JD, MPH
    Rachel Turow, JD, MPH Managing Counsel, FDA Regulatory
    Walmart, Inc., 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, Federal Affairs
    Johnson & Johnson, United States
  • Kirsten H. Paulson, MS, RAC
    Kirsten H. Paulson, MS, RAC
    Pfizer, Inc., United States
  • Kim Quaintance-Lunn
    Kim Quaintance-Lunn Vice President, Regulatory Affairs Americas
    Bayer AG, United States
  • John Weiner, JD
    John Weiner, JD Associate Director for Policy, Office of Combination Products, OCPP, OC
    FDA, United States

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