Menu Back to Combination-Products-Conference

Overview

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.


Content Preview On-Demand Webinar

The “Perfect Storm” – How Global Regulatory Changes Over the Next Few Years Could Affect Combination Products
The impending changes for combination products across the globe will increase the difficulty of navigating the regulatory landscape. When should companies start preparing for these changes? This presentation will lay out challenges and timelines of global regulatory changes, so senior management can appropriately develop their regulatory strategies to keep facilities in compliance and products on the market.
Register today.






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.

Who should attend?

Senior Level Professionals and Decision-makers 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:

 

  • Discuss recently issued guidances and regulations as well as internal FDA changes affecting combination products 
  • List examples of challenges faced in the development of complex generic combination products
  • Outline best practices of handling adverse effects, usability, and complaints throughout the drug-device lifecycle
  • Explain key considerations in determining the appropriate regulatory submission path for a combination product
  • Identify how the agency is collaborating with industry to encourage innovation
  • Describe the importance of compliance with the EU MDR and specific provisions on combination products
  • Recognize the characteristics of an appropriate Quality Management System for a connected combination product manufacturer
  • Describe the top issues affecting both drug and device led combination products

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 VP Quality Regulatory Affairs
    Pear Therapeutics, Inc., United States
  • Ryan  McGowan
    Ryan McGowan Associate Director, Combination Products
    AstraZeneca, United States
  • Kirsten H. Paulson
    Kirsten H. Paulson Senior Director, Global CMC Medical Devices
    Pfizer Inc, United States
  • Nancy  Stade, JD
    Nancy Stade, JD Partner
    Sidley Austin LLP, United States
  • James  Wabby, MS
    James Wabby, MS Executive Director, Regulatory Affairs, Devices and Combination Products
    Allergan, United States
  • John Barlow Weiner, JD
    John Barlow Weiner, JD Associate Director for Policy, Office of Combination Products, OSMP
    FDA, United States
  • Bill  Zeruld
    Bill Zeruld Business Development - Digital Strategy
    Otsuka America Pharmaceuticals, Inc., United States
Load More

Contact us

Registration Questions?

Send Email
1.888.257.6457


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!


Digital Learning Catalog

DIA Learning: 2018 eLearning Soultions
Download