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?
Content Preview On-Demand WebinarThe “Perfect Storm” – How Global Regulatory Changes Over the Next Few Years Could Affect Combination Products
The 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.
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.
Who should attend?
Senior Level Professionals and Decision-makers involved in:
- Biopharmaceutical, Device, and Combination Product R&D and Development
- Regulatory Affairs
- Clinical Research
- Consulting, Legal, Government Affairs
- Quality Assurance and Control
- Business Development
At the conclusion of this conference, participants should be able to:
- Discuss recently issued guidances and regulations as well as internal FDA changes affecting combination products
- List examples of challenges faced in the development of complex generic combination products
- Outline best practices of handling adverse effects, usability, and complaints throughout the drug-device lifecycle
- Explain key considerations in determining the appropriate regulatory submission path for a combination product
- Identify how the agency is collaborating with industry to encourage innovation
- Describe the importance of compliance with the EU MDR and specific provisions on combination products
- Recognize the characteristics of an appropriate Quality Management System for a connected combination product manufacturer
- Describe the top issues affecting both drug and device led combination products
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
Complex Drug-Device Generic Combination Products Meeting
*Save $100 when you register for both at the same time!