Pre-Conference Workshop Day
TUESDAY, SEPTEMBER 20, 2022
Workshop A - 9.00am – 11.00am
Combination Product – Drug & Device Integration
Streamline your end-to-end combination product lifecycle management process
Ensuring a quality combination product (CP) with minimal risk and cost has become a new battleground for today’s top companies. A big part of your product’s success hinges on end-to-end adoption of lifecycle management within your development program.
This workshop will enable you to:
- Create a control strategy for your combination product to safeguard patients
- Identify combination products risk considerations
- Outline key considerations for human factors and usability engineering
Workshop Leaders:
Olivia Wong
Director, Quality, Device & Combination Products
Gilead Sciences
Marycruz Alvarez
Senior Manager, Quality Assurance, Combination Products
Gilead Sciences
Workshop B - 12.00pm – 2.00pm
EPR Interpretation & Putting it into Practice
In this workshop, we demystify essential performance requirements to achieve a fast product development & smooth documentation process. The workshop delves into the following:
- What are Essential Performance Requirements (EPR) and essential design outputs?
- How do we identify EPRs?
- What are the considerations for EPR control strategy?
Workshop Leader:
Abhishek Telang
Associate Principal Scientist, Devices & Drug-Device Combinations CMC
Merck
Workshop C - 3.00pm – 5.00pm
Ergonomics and Usability of Combination Products for Self-Injection
In this workshop, we will discuss and expand your knowledge in the various factors that contribute to the success of injection devices – including physical and emotional considerations, as well as risks that a Human Factors Engineer should consider. Through interactive exercises and case studies, we will discuss and seek solutions to:
- Does a well-engineered device always translate into well-designed?
- What impact does patient behavior and physical ability have on self-injection adherence?
- How does patient motivation differ with various health conditions?
- How can we design devices for low literacy/low health literacy patients?
Dan Formosa
Designer
ThinkActHuman