8:00 am Breakfast & Registration

9:00 am Chair’s Opening Remarks

The Winning Partnerships to Develop a Winning Combination Product

9:10 am Keynote Address: Building the Engagement and Dialogue with the FDA

Synopsis

  • CDER vs Combination Products – who should you talk to?
  • Current framework from the FDA and when you should start engaging?
  • What does the regulatory agency expect?
  • Q&A

9:40 am Case Study: How Can Quality Contribute to a Winning Product and LCM?

  • Raihan Hossain Associate Director of CH I&D Medical Device Quality, Bayer

Synopsis

  • Change is constant – how should you handle that pre- and post-launch?
  • Can you simplify your process without compromising on quality?
  • Creating a process that help you mitigate risks – a case study of employing these techniques to manage change and CAPA

10:10 am Panel Discussion: What Does a Good Control Strategy Look Like and Its Importance to Drive a Sustainable Lifecycle?

  • John McMichael Associate Director, Combination Products, AstraZeneca
  • Raihan Hossain Associate Director of CH I&D Medical Device Quality, Bayer

Synopsis

  • From start to finish – is there an end-to-end change control for your combination products?
  • Defining the processes and understanding what the FDA expects for quality control and assurance
  • It’s not a check-box exercise – developing a robust control framework to drive a sustainable LCM for your combination products to optimize your development timeline, costs and quality of products

10:40 am Morning Refreshments & Networking

11:10 am Catching Up on the Digitalization Trend?

  • John Schalago Head, Global Regulatory Affairs, Devices & Applications, EMD Serono

Synopsis

  • Are you all connected? Understanding the rapidly evolving regulatory framework
  • What does it mean for your go-to-market strategy? The different scenarios for legacy products and candidates in the pipeline
  • What are your considerations and how should you handle post-market surveillance reporting with the boom of  connectivity?

11:40 am Is Connectivity the Answer?

Synopsis

  • Is ‘app’ everything patient need?
  • The overwhelming support from the FDA for connected devices
  • Opportunities and risks in connected device
  • From a single product entity to building an ecosystem to realize the full potential of digital combination products for best patient insights
  • How to deploy and apply digital in clinical trials to accelerate timeline?

12:10 pm What Innovations Do You Need to Extend Your Combination Product Lifespan?

Synopsis

  • Device design matching tomorrow’s patients’ needs
  • From concept to R&D to commercialization: how should engineering team collaborate with other functions
  • It doesn’t need to be revolutionary – incorporating UX to drive product development

Session Reserved for Program Partner

12:40 pm Lunch & Networking

1:40 pm Master Mind: How to Transition from a Mechanical to Electro- Mechanical Drug-Device Product?

Synopsis

Connectivity is definitely the trending buzzword in 2018. While we have seen a surge of projects and activities across drug and device manufacturers, the transition from a pure mechanical to electro-mechanical drug-device isn’t easy. In this mastermind session we will explore the following themes and seek solutions:

Who Should be Involved? Different Areas of Consideration
  • Regulatory Affairs/ CM
  • Device Engineers
  • Software & hardware development
  • IT, Infosec & cybersecurity
  • Risk & quality management
  • Commerciality
  • Usability
  • Cybersecurity
  • Patient data security
  • Battery and device management

Audience will be split into a group of 10. During the 30mins exercise and discussion, each group will have the opportunity to re-work the organization and process flow chart, and share your recommendation with the rest of the audience at the end of this session for comparison and contrast.

2:20 pm Building a Digital Ecosystem & Driving Product Innovations

Synopsis

  • It’s also the ancillary services you need to consider – what is a truly connected device offering?
  • How will this help increase your product life span and commercial competitiveness?
  • The agile approach and winning your customers’ hearts

2:50 pm Chair’s Closing Remarks & Close of Conference