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 ProductsGain 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.
On-Demand Complimentary Webinar
Combination Products Postmarketing Safety Reporting: Overview, Challenges, Solutions
This webinar will provide an overview of the safety reporting requirements of the final rule and assess the areas that are likely to present the greatest compliance challenges. Real-world, least burdensome approaches to compliant postmarket safety reporting for US and globally marketed combination products will be discussed and industry best practices highlighted.
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.
Rachel SW Turow, JD, MPH • Executive Counsel, Regulatory Law
Teva Pharmaceuticals Ltd., United States
David Amor • Vice President, Quality and Regulatory
Pear Therapeutics, United States
Ryan McGowan • Associate Director, Combination Products
AstraZeneca, United States
Kirsten H. Paulson, MS, RAC • Senior Director, Global CMC Medical Devices
Pfizer Inc, United States
Nancy Stade, JD • Partner
Sidley Austin LLP, United States
James Wabby • Executive Director, Regulatory Affairs Devices and Combination Products
Allergan, United States
John Barlow Weiner, JD • Associate Director for Policy
FDA, United States
Bill Zeruld • Business Development - Digital Strategy
Otsuka America Pharmaceuticals, Inc., United States
Registration Questions?Send Email
How the MDR will Affect Combination Products
Complex Drug-Device Generic Combination Products Meeting
*Save $100 when you register for both at the same time!