Overview

Combination Products 2016: Current, Evolving, and Future Pathways

October 24: Short Course (PM)*
October 25-26: Conference
Short Course: Digital Health Technologies for Combination Products and Beyond: Development and Regulation

*Short Courses require registration and are an additional fee

The increasing use of and interest in innovative combination products – products combining a drug, device, and/or biologic – is raising significant challenges both for regulators and the industries they regulate. To bring these promising new therapies to market, innovators must often overcome challenges resulting from differences in policies, development processes, and review pathways. Combination Products: Current, Evolving, and Future Pathways examines policy and regulation of combination products and their impact on the life cycle of these products. The conference will also examine recent organizational developments and review process improvements at FDA that are aimed at addressing the unique regulatory needs of combination products. Possible new paradigms for developing drugs and devices together will be explored, and the evolving potential of convergence across FDA’s centers, as piloted by the Oncology Center of Excellence, will be discussed as a model for innovation and how it may relate to combination product regulation.

Network early and start engaging on social media using the hashtag #DIACombo2016.

Featured topics

Regulatory and legislative updates (US and EU)
Organizational and review process developments at FDA
Addressing challenges of the different review paradigms and pathways for drugs, biologics, and devices
FDA Oncology Center of Excellence: Implications for Intercenter Coordination
Digital Health Technologies: Software mobile medical apps and clinical decision support
Policies for medical product innovation and what they mean for combination products

Featured

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Who should attend?

Senior Level Professionals and Decision-Makers involved in:

Biopharmaceutical, device, and combination product R&D and development
Policy
Regulatory Affairs
Clinical Research
Consulting, Legal, and Government Affairs
Quality assurance and control
CMC
Business Development

Learning objectives

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

Describe legislative and regulatory developments pertaining to combination products in the US and EU
Understand and discuss differing perspectives and approaches of drug and device development and regulation, and implications and opportunities for combination product regulatory practice and policy
Discuss developments and opportunities for facilitating innovations in medical product development through collaborative regulatory approaches such as the FDA Oncology Center of Excellence

Short Course or Primer

To keep you at the forefront.

Oct 24, 2016

Course:

Digital Health Technologies for Combination Products and Beyond

Learn more

Oct 24, 2016

Course:

Digital Health Technologies for Combination Products and Beyond

Learn more

Program Committee

Steven B. Binion Director, Policy, Technology, and Communication - Corporate Regulatory Affairs
Becton Dickinson, United States
David E. Paul, JD Consultant, US Regulatory Affairs, Policy and Strategy
Eli Lilly and Company, United States
Kim Quaintance-Lunn Vice President, Head of Regulatory Science and Execution
Alexion, United States
Rachel Turow, JD, MPH Managing Counsel, FDA Regulatory
Walmart, Inc., United States
John Weiner, JD Associate Director for Policy, Office of Combination Products, OCPP, OC
FDA, United States