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Sept 5 – 7, 2018
San Diego

Day One
Wednesday September 27, 2017

Day Two
Thursday September 28, 2017

Breakfast & Registration

Chairman’s Opening Remarks

Navigating Through the Global Regulatory Framework

Keynote Address: What is a Quality Device? Applying Risk-Based Design & QbD Approaches


• Ensuring QbD and design validation encompassing ICH Q9 risk management approach
• Taking a risk-based approach during device design and control strategy
• Applying software for accurate simulation and evaluation to increase confidence level

Combination Products Part 4 Compliance & Implementation at Multi-Site Networks Including CMOs

  • Vijay Damodaran Advisor/Director, Quality, Medical Devices & Combination Products, Eli Lilly & Company


• Evaluating key cGMP requirements for combination products
• How to perform effective compliance oversight when multiple sites are involved in the design, development and manufacturing of combination products?
• Ensuring compliance to EU requirements for drug/device medicinal products
• Achieving inspection readiness for combination products

Post-Market Surveillance Requirements – How to Implement?

  • Nathalie Yanze Senior Director, Regulatory Affairs , Coherus BioSciences, Inc.


  • Evaluating the final rule of post-marketing safety reporting requirements for combination products
  • Discussing the implementation challenges, and opportunities for regulator and industry
  • Establishing an on-going and rigorous post-market surveillance strategy to identify product, design, and process improvements

Morning Refreshments & Speed Networking

Technical Innovations for PFS & Injectables

Interface from PFS to Auto-Injector

  • Joyce Zhao Associate Director, Device Engineering & Development, Dr. Reddy’s Laboratories


• Exploring the undeniable benefits of auto-injectors over PFS for patients
• Considerations during the device development cycle: Compatibility between PFS and autoinjector, drug viscosity, intended use and patient group
• Addressing the challenges of quality control and device assembly for auto-injectors
• What’s next? Discovering how wearable injectors can deliver a higher volume and viscous drug

Lifecycle Management of Your PFS & Injectable

  • Anthony Trupiano Senior Director, Drug Delivery & External Manufacturing, Shire


• Analyzing product life cycle management from vial to PFS and beyond
• Evaluating specific requirements and considerations for combination product development
• Discussing the impact of connectivity on lifecycle management
• Emphasizing the importance of user research to maximize device lifespan

Lunch & Networking

Success Story of Developing a Patient-Centric Device

  • Young Chun Principal Engineer - Human Factors Lead, Shire


• Assessing HF roles from start to finish and beyond
• From pre-filled syringes to autoinjectors to other devices: Lessons learnt on HF study
• Tackling the challenge of conducting HF study for rare diseases/orphan drugs
• Exploring techniques that can help collate and incorporate user feedback to device design

The Human Touch – Develop a Patient-Centric Injectable Device

  • Molly Story Global Usability Engineering & Risk Management, MED, Sanofi


• Achieving design validation in compliance with 21 CFR Part 820:30 and ISO 62366-1:2015
• Defining your intended users and user groups for validation
• Understanding the human factors process and feedback loop to enhance device quality and minimize delay in device development
• How can early human factors evaluations give your device a competitive edge?

Afternoon Refreshments & Networking

Roundtable Discussion


The audience can choose a specific topic to discuss and share their challenges with colleagues. Through open dialogues, we hope to facilitate knowledge exchange and inspire innovative ways to find solutions to your daily problems.

Track 1: How to conduct human factors studies as part of your clinical development program?
Track 2: Quality issues: Update PQRI guidelines and best practice to E&L and viscosity issues in injectable devices?
Track 3: Regulatory pathways for combination products in PFS and injectables
Track 4: Future digital device – how should we envisage the connected platforms to drive patient-centricity?

Next Generation Dose Delivery Devices

  • Thomas Miller Vice President, Device Research & Innovation, Novo Nordisk


• Identifying new ways to support patients
• Lessons learned so far – incorporating formative human factors study into your user-testing for smart devices
• Looking into the future – what’s next and what are the potential challenges?

Chairman’s Closing Remarks

Close of Day One