Short Course: October 28
Conference: October 29-30
Combination products, comprising a drug, generic, or biologic and a device, have emerged as innovative medical products whose impact will continue to grow in the coming years. The convergence of innovative medicines such as advanced cell and molecular biological products (Advanced Therapeutic Medicinal Products or ATMPs), materials science advances, and the development of digital therapies and applications is driving a rapid expansion of novel applications to better meet patient needs. Though substantial legal and regulatory developments in the past two to three years have improved the framework for combination product development, regulatory policies and processes will continue to evolve with the technology. Fundamentals such as quality systems and lifecycle management programs are evolving as well.
DIA's Combination Products Conference will examine the current US and global regulatory environments for combination product development and approval, including new FDA regulation and guidances, and late-breaking information on implementation of the EU Medical Device Regulation. Unique aspects of combination product development and lifecycle management that drive ongoing regulatory change will be explored, with a close look at the impact of CATMPs, generic combination products, and co-development of digitally connected combination products such as drug companion apps and digital monotherapies. Best practices for approaching regulators with novel product ideas and for obtaining Agency feedback on regulatory issues will be discussed with regulators in an interactive format.
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?
Need approval in order to attend?Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
- Advanced Therapies Moving Upon Combination Platforms
- Regulatory Landscape of Drug-Device Combination Products
Who should attend?
Senior Level Professionals and Decision-makers involved in:
- 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
- Interrelate pharmaceutical development practices to demonstrate design control compliance
- Discuss recent regulatory changes and guidance in the areas of emerging technologies and best practices for approaching regulators with novel combination product ideas
- Describe key clinical study design considerations for connected combination products including unique endpoints and instrumenting for RWE collection
- Describe challenges and opportunities in lifecycle management programs for complex Combination Advanced Therapeutic Medical Products (CATMPs)
James Wabby, MHS • Executive Director, Regulatory Affairs, Emerging Technologies and CMC - Device
AbbVie, 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
Rachel Turow, JD, MPH • Associate General Counsel, Regulatory Law & Policy; Head, U.S. Regulatory Policy
Teva Pharmaceutical Industries Ltd., United States
John Barlow 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