Agenda and Expectations for the 2024 Combination Products Summit: Navigating the Future of Healthcare

The healthcare landscape is constantly evolving, and with it, the need for innovative solutions in combination products—those unique blends of drugs, devices, and biologics that present distinct challenges for development and commercialization. The 2024 Combination Products Summit is the premier event where industry leaders, regulators, and experts come together to tackle these challenges head-on.

This year’s summit promises to be more impactful than ever, offering a comprehensive agenda that will equip professionals with the knowledge and tools they need to navigate the complexities of combination products in a dynamic regulatory environment.

When and Where

• Date: October 8-10, 2024
• Location: Providence, Rhode Island, 1 Orms St, Providence, RI 02904-2221

What to Expect

1. Pre-Conference Workshop (October 8, 2024)

The summit kicks off with a full-day pre-conference workshop designed to delve deep into the specific challenges of combination products. Moderated by top industry experts like Chin-Wei Soo of Genentech/Roche and Jason Lipman of Sanofi, the workshop will cover essential topics including:

• Digital Health Technologies for Remote Data Acquisition
• Artificial Intelligence and Machine Learning in Medical Devices
• Aligning Risk Management Approaches Between Stakeholders

This workshop is ideal for professionals at all levels, offering a unique opportunity to engage with experts and peers, explore real-world case studies, and gain actionable insights that can be applied immediately to current projects.

2. Main Summit (October 9-10, 2024)

The main event spans two days of in-depth sessions, discussions, and networking opportunities that focus on the most pressing issues facing the combination products industry. Some of the key sessions include:

• FDA Office Hours: A chance to meet with staff from the FDA’s Office of Combination Products (OCP) to get your questions answered directly by the regulators.
• Strategic Priorities from the FDA’s Office of Combination Products: Hear from James Bertram, Director of the OCP, and other FDA officials about the current and future regulatory landscape.
• On-Body Delivery Systems: This session will explore the critical aspects of on-body injection system design and regulatory considerations.
• Harmonizing U.S. FDA’s QMSR to ISO 13485: Understand the impact of recent regulatory harmonization on combination products and how to prepare.

3. Networking Opportunities

In addition to the formal sessions, the summit offers numerous informal collaboration and networking events. These are invaluable for building connections, exchanging ideas, and fostering partnerships that can drive innovation and success in the combination products space.

4. Real-World Applications and Learning

The summit emphasizes not just learning but applying that knowledge in the real world. Attendees will participate in interactive case studies, engage with peers on practical challenges, and leave with a clear plan for implementing what they’ve learned.

Why You Should Attend

The 2024 Combination Products Summit is more than just a conference; it’s an opportunity to be at the forefront of an industry that’s crucial to the future of healthcare. Whether you’re new to the field or a seasoned professional, this summit offers:

• Comprehensive Lifecycle Knowledge: Gain the ability to navigate the entire journey from development to commercialization with confidence.
• Regulatory Insights: Learn how to conquer the complex landscape of global regulations.
• Risk Management Expertise: Develop the skills to identify, assess, and mitigate risks specific to combination products.
• Networking: Build connections with industry leaders and experts who can support your professional growth.

Final Thoughts

As the healthcare industry continues to evolve, staying informed and connected is more important than ever. The 2024 Combination Products Summit offers a unique opportunity to gain insights into the latest developments in combination products, with a focus on real-world applications, regulatory updates, and expert-led discussions. I’m looking forward to attending, learning from industry leaders, and connecting with others facing similar challenges in this dynamic field. I’m excited to take part in the conversations shaping the future of combination products.

To register or learn more, visit: https://healthcareproducts.org/hpc-events/2024-about/