概要
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 ProductsThe 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.
プログラム委員会
-
Rachel Turow, JD, MPH Managing Counsel, FDA Regulatory
Walmart, Inc., United States -
David Amor Digital Health - QA/RA
Apple, United States -
Ryan McGowan Associate Director, Combination Products
AstraZeneca, United States -
Kirsten H. Paulson, MS, RAC
Pfizer, Inc., United States -
Nancy Stade, JD Partner
Sidley Austin LLP, United States -
James Wabby, MHS Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
AbbVie, United States -
John Weiner, JD Associate Director for Policy, Office of Combination Products, OCPP, OC
FDA, United States -
Bill Zeruld Business Development - Digital Strategy
Otsuka America Pharmaceuticals, Inc., United States
