Short Course: October 7
Meeting: October 13-14
Combination products can advance patient therapy by combining and utilizing innovative technologies to deliver treatment. Although these products can be beneficial and lifesaving to the patient, industry may find it difficult to develop and maintain a sound, consistent approach to lifecycle management. Industry is keenly aware that the key to ensuring quality and safety in the lifecycle of a combination product is effective risk management. Properly conceived, risk management offers a holistic framework and process to identify and address the full sweep of considerations for development, efficacy, as well as safety investigation, manufacturing, and the safety and efficacy of post-marketing changes. However, risk managment may be complicated by the challenges of managing the regulatory expectations within and across jurisdictions, and the complexity of applying multiple guidances from pharmaceutical and device development to the combination product.
The DIA 2021 Special Topic: Risk Management in Combination Product Development Conference will focus its efforts on educating attendees about risk management from both an industry and global regulatory perspective, to continue to create the framework for a clear and consistent approach to product development, management, and regulation. This conference will showcase how a risk-based approach can help guide an understanding of ways in which drug and device-led combination product categories may be similar and different, and how these attributes should inform product stewardship and regulation.
This event will provide a space for global stakeholders to virtually gather to solve a complex problem and provide answers to key questions:
- How can we develop a consistent strategy for the application of risk management documents and for clarity of engagement with regulators?
- How can risk management be leveraged across the product lifecycle with an emphasis on premarket considerations from an industry and global health regulator perspective?
- How can case studies from combination product development be applied to assess best practices for industry and regulators considering the relative risk profiles of these categories of products?
Who should attend?
- Biopharmaceutical, Generics, Biosimilars, Device, and Combination Product R&D and Development
- Business Development
- Clinical Research
- Legal, Government Affairs
- Quality Assurance and Control
- Regulatory Affairs, Regulatory Operations
- Research and Development
- Discuss the holistic risk-based approach for combination product life cycle management and become familiar with best practice considerations for successful implementation
- Create a risk management process that encompasses all stages of the lifecycle for a device-led, drug-led, or digital combination product
- Discuss the necessary risk management knowledge and skills needed to meet global regulatory requirements for combination products
- Apply lessons learned from real-world examples using market feedback to continuously update earlier risk management assumptions and living risk files
- Discuss the current digital health regulatory frameworks, and apply FDA guidances and documents to determine whether your digital health product meets the definition of device
James Wabby, MHS • Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
Abbvie, United States
John Barlow Weiner, JD • Associate Director for Policy, Office of Combination Products, OCPP, OC
FDA, United States
Jonathan Amaya-Hodges • Senior Principal Consultant
Suttons Creek, Inc, United States
Karthik Balasubramanian, PhD, MS • Director, Combination Products and Semisolids, Generic CPD
Teva Pharmaceuticals, United States
Susan W. Neadle, MS, MSc • Medical Device, Combination Products, Design Thinking, Process Excellence
and Program Management Expert, United States
Chin-Wei Soo, DrSc • Global Regulatory Head, PTR Devices and Combination Products
Genentech, A Member of the Roche Group, United States
Kimberly Trautman, MS • Medical Device, IVD, and Combination Product Expert
*, United States