Pre-Conference Workshop Day


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

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

Dan Formosa