The breadth of the material and the expertise of the instructors was very impressive."
Karen Long, Regulatory Affairs in the Life Sciences student
Karen Long has worked in regulatory affairs and drug and device development in Vancouver for more than 30 years. As a long-time member of the Regulatory Affairs Professionals Society who holds four Regulatory Affairs Certifications (RAC), Karen believes there is always more to learn.
What led you to seek out this program and what were you hoping to gain?
Every year I try to challenge myself to learn something new. This has taken the form of writing book chapters, presenting at conferences, or taking a program like Regulatory Affairs in the Life Sciences. The field of regulatory affairs is always changing, so I wanted to keep my knowledge up to date, particularly in biologics. I also wanted to understand the reimbursement process better.
What was a highlight for you from the program?
Hasnaa Fatehi gave a tour de force presentation at the medical device regulation workshop! It was also fun to meet my fellow online learners in person. They came from many different professional backgrounds, so it was so interesting to do the peer reviews and see the material through their eyes.
What surprised you about the course? Were there any lessons or techniques from the courses that you found particularly helpful?
The breadth of the material and the expertise of the instructors was very impressive. I can now use ICER and QALY in a sentence! These are terms used to determine if a new therapy is cost-effective, which is very important for developers working on their cost of goods.
How are you applying the skills you learned in your personal or professional life?
I am working on a new biologics project now and I am definitely putting what I learned in the chemistry module to good use.
Who would you recommend this program to?
It is meant to be a broad survey course, hitting the highlights of each aspect of new product development. So, I would recommend the program to a person who specializes in one aspect (e.g., clinical, research, quality or project management) to get a broader picture of the overall new product development process.
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