8:00 am Welcome Coffee & Registration
9:00 am Chair’s Opening Remarks
- James Wabby Executive Director of Regulatory Affairs, Combination Products & Devices , AbbVie
How to Manage Impending Regulatory Changes
9:10 am Keynote Address: How to Remediate Changes to Regulations & Offer Effective Drug Delivery
- John Weiner Associate Director, Office of Combination Products , FDA
• Reviewing the changes to regulatory framework and agency requirements
• Building dialogue and engagement within the FDA – who should you talk to?
• Exploring the impacts of the MDR on the success of getting your product to market
• Determining how to purpose regulation changes to your advantage
• Proactively understanding specific regulation requirements for your product to provide accurate and efficient documentation
9:40 am Preparing for Imminent Changes – Modifications in Post-Market Safety Reporting
- Khaudeja Bano Executive Medical Director, Combination Product Safety Head & Global Patient Safety, Amgen
• Outlining the changes to post-market safety reporting in 2020
• How this has changed the landscape of adverse event reporting and impacts on your operations?
• Explore how to implement these changes effectively within your drug and device teams
• What are they key challenges?
• Simplifying these changes through risk management documentation
• How does post-market safety affect costings?
10:10 am Speed Networking & Morning Refreshments
The dynamic way to network. Meet your colleagues and make valuable and lasting connections
11:10 am Essential Performance Requirements – Highlighting the Requirements for a Fast Product Development & Smooth Documentation Process
- Susan Neadle Senior Director, Global Quality Design , Johnson & Johnson
• Reliability testing, human factor testing and safety reporting – the function of the IEC and how to utilize this document to aid optimal drug-device development
• Adhering to standards to avoid post-launch re-approval, excess documentation and costs
11:40 am Panel Discussion – What Does the Relationship Between Drug Development & Regulatory Agencies Need to Look Like to Optimize Combination Product Development’s Time & Cost Effectivity?
With the fast-evolving regulatory framework, strong communication and a common understanding between the FDA, notified bodies and the primary market is essential. We will be asking our panel to share their experience and thoughts on:
• Corresponding agencies’ expectations and requirements
• Striving for a positive collaboration to aid drug-device development and effective patient treatment
12:30 pm Networking Lunch
Implementing Effective Lifecycle Management to Ensure Your Commercial Competitiveness Globally
1:30 pm The Early Adopter: Embed LCM into Your Development Program to Minimize Risks & Costs
- Paul Chao Associate Director, Combination Product Development, Regeneron Pharmaceuticals
• Optimize development time, costs and reduce risks through early LCM implementation
• With the dynamic regulation framework, ensuring a clear roadmap to drive product development
• Address the different requirements for your drug and device – produce a collaborative and inclusive LCM strategy
• Ensure a quality CP with minimal risks in a cost effective and timely manner
2:00 pm How Can Cross Functional Teams Work Together at Launch Point?
• How can commercial & launch readiness be optimized by ensuring the whole team is connected onto the same design
• From design and change control to managing field suppliers and obtaining quantity agreements – ensure all documentation from various teams are complete at launch point to – prevent barriers to quality, processes and product
2:30 pm A Pragmatic & Strategic Framework – Balancing a Consistent Top-Level Strategy with Product Specificity
- Andrew Yum Director of Medical Device Development, United Therapeutics
• Developing a robust framework which will produce consistency and clarity regrading development and associated regulations
• Knowing how to mold the framework to best fit your product through understanding the specific requirements for your drug-device
• How can you decide the most effective strategy to target your CP?
3:00 pm Afternoon Refreshments & Networking
3:30 pm Effective Lifecycle Management Strategies to Implement Throughout the Product Development Lifecycle
- Ram Halthore Director of Engineering, Merck
• Explore how to optimize your combination product development through effective lifecycle management strategies
• Best practices to ensure a streamlined product development incorporating voice of manufacturing
• Discuss the necessity to ensure an effective ongoing commercial supply
4:00 pm Discover, Develop & Deploy – Pre vs Post-Launch: Exploring the Distinctions in Risk Management Strategies
- Raihan Hossain Risk Lead, Device Engineering Lifecycle Management, Pfizer
From pre-clinical observations, processes, data control and differences in terminology, understanding these differences between pre and post launch risk management can help you effectively coordinate your activities.
In this interactive session, we will split the audience into groups of 10. You will then hear an introduction from Pfizer, which will be followed by a Q&A session. Tables will then be asked to discuss amongst their group their understanding and experiences of risk management strategies, including how they will look to implement these strategies within their work. A leader from each group will present their tables findings to the rest of the audience.
• Discover: the differences between the strategies implemented during pre-clinical activities through to post-launch operations. How can you manage the differences to maintain a quality and legitimate product?
• Develop: which strategies you think are most effective for achieving smooth transition after product launch
• Deploy: implement effective risk management strategies into your work at both pre and post launch. How will you manage the different processes to reach commercial competitiveness and success?