Human factors are a critical factor for any drug, medical device, or combination product entering the market. From self-injected drug products to complex surgical devices, human factors should be considered throughout the lifecycle of a product.

On June 29 Regulatory Mark Founder Alison Sathe and Kaleidoscope Innovation Director of Insights and Human Factors Valerie Fenster presented the Redica Systems webinar, “Human Factors – Compliance and Applications.”

The webinar is now available for instant download.

June webinar download

What You Will Learn

  • Human factors strategies from simple drug products to complex surgical devices
  • Primary and secondary labeling development and evaluation for usability
  • Human factors activities from product development to post-market
  • International strategies: expectations for human factors in regulatory submissions in international markets

Who Will Benefit

Anyone involved in the development and post-marketing of drug products, medical devices, and combination products. Compliance and regulatory affairs teams will find the information presented valuable as well.

About the Presenters

Alison Sathe

Alison Sathe founded Regulatory Mark and ClearMark to provide best-in-class regulatory and quality consulting and electronic quality management systems solutions for medical devices to her domestic and international partners. As a biomedical engineer, she began her career working in medical device startups and has specialized in regulatory and quality affairs for over 15 years.

Valerie Fenster

Prior to working at Kaleidoscope, Valerie Fenster founded and developed a Human Factors Engineering group at Amgen. She successfully guided the human factors process and regulatory filings for combination products such as Enbrel®, Repatha®, and Aimovig® SureClick® autoinjectors and prefilled syringe devices.

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