8:00 am Morning Coffee & Registration

8:50 am Chair’s Opening Remarks & Recap of Day One

  • James Wabby Executive Director of Regulatory Affairs, Combination Products & Devices , AbbVie

Control your Combination Product Post-Market Operational Changes

9:00 am Opening Address: Managing Changes from Early Stage to Commercialization through Excellent Design Control

  • Dana Korkuch Head of Quality Device & Combination Products, Sanofi


• Exploring how to scale design controls to be phase appropriate for early clinical studies
• Bridging – understanding how to set this up and leverage early stage design controls to allow for efficient bridging to late stage and commercialization when anticipated design changes are known

9:30 am Utilizing Incremental Face-Lifts to Your Product to Minimize Regulatory & Documentation Requirements to Enhance Patient Loyalty


• Understand the regulatory requirements for implementing post-market changes
• Tailor your development strategy to produce a powerful and practical 2nd generation product
• Exploring how to make changes to your legacy product with minimal re-approval documentation

10:00 am Spotlight Case Study – How Amgen Produced a Winning Quality & Effective Combination Product

  • Chandra Ma Senior Manager, Global Regulatory Affairs CMC, Device and Biosimilars, Amgen


Enbrel – a biologic medicine used to treat inflammatory conditions, from a single-use autoinjector to an electromechanical reusable autoinjector.

  • Discover how LCM was expertly managed, permitting product development.
  • With the ever evolving and crowded market, hear first-hand how the post-market operations and regulatory challenges were addressed.
  • Design with patients in mind.

10:30 am Morning Refreshments

11:00 am The Fast-Evolving Landscape; Post-Market Change is Essential to Ensure Commercial Competitiveness & Optimal Patient Treatment


• Exploring why change is essential in the growing market
• How to collaborate internally and externally most effectively to manage change
• Shaping post-market changes to meet patient requirements and avoid excess costs
• Using post-market surveillance and consumer feedback to recognize change requirements

11:30 am Speed Learning – Risk management


The audience will be given 3 specific topic questions to discuss and share their challenges with colleagues. Through open dialogues, we will facilitate knowledge exchange and spark inspirations to help you find solutions to your daily problems.

This is your opportunity to have direct and candid dialogue with your combination products colleagues. We will split the audience into small groups. Each group will have 20 minutes to discuss each topic with the table leader, before moving onto the next. At the end of the session, topic leaders will present findings to the group. The objective is to offer 1 top tip for the rest of the delegation on each of the following:

Track 1: What does a good QMRS framework look like and how do you effectively implement to minimize risk?

Track 2: What are the risks surrounding clinical bridging? Do these outweigh the benefits?

Track 3: What are the post-market impacts on risk management?


12:30 pm Networking Lunch

The Next Generation: The Convergence of Device in Pharmaceuticals & the Future for Combination Products

1:30 pm Is Software the Answer – How Will Combining Software with Digital Devices Improve Health Care & Increase Patient Experience?

  • H.E. Sengoku Director, GRL Medical Devices/ Combination Products, UCB, Inc.


• Software devices in digital medicine seems to be the next step for the CP landscape. What are the regulatory implications of this, and can it truly enhance patient treatment?
• Combining smart devices and wearable technology to deliver your drug in a dynamic, easy and accessible way
• The FDA’s response to the progression into digital health

2:00 pm How Do You Transition into the Next Generation? Discovering the Requirements for a Successful Evolution to a Next Generation CP

  • Leonel Vanegas Device Clinical Development Quality, Alexion Pharmaceuticals


• Outlining how to search for change opportunity to understand how and when to take your drug-device to the next generation
• Ensuring you have an efficient organizational structure and qualified resources to manage these products
• Managing a cross-functional understanding between pharma, biologics and device experts – communication and positive collaboration is essential for product effectivity

2:30 pm Spotlight Case Study – Digitalizing the Next Generation: The Regulatory Implications of a Digital Future


• What does digitization mean for the future of CP?
• Understanding the regulatory framework for digitalization of drug-devices – exploring how collaborations result in a more complicated documentation process
• Exploring the challenges posed regarding risks and security for smart devices

3:00 pm Chairs Closing Remarks & End of Summit