The keys and obstacles to learning about regulatory pathway assessment
Regulatory pathway assessment is a foundational skill for regulatory affairs professionals. It is “really the building block of a regulatory strategy,” says Michelle Lott, a RAPS member who worked with RAPS Online University to create the new How to Conduct a Regulatory Pathway Assessment Series.
This three-part online course series introduces regulatory professionals to the idea of regulation as a strategy. The courses emphasize the steps that all medical device products go through to reach commercialization. Key topics include FDA risk-based classification, submission types, and navigating FDA databases to architect a complete regulatory strategy.
Michelle joined RAPS to explain the foundations of regulatory strategy, how she learned these skills and why she decided to help RAPS create this course series.
Hi Michelle! Can you introduce yourself?
I'm Michelle Lott. I am the founder and principal of leanRAQA. We help small to midsize companies navigate their regulatory pathway requirements through their submissions and into commercialization with their quality management system. I have worked with RAPS in several different capacities, but most recently on creating a series educating people on how to conduct a regulatory pathway assessment from the ground up.
What is regulatory pathway assessment and why do regulatory professionals need to know about it?
A comprehensive regulatory pathway assessment is really the building block of a regulatory strategy. So, any time you have a new product or modifications to an existing product or an intended use, you need to scavenge the FDA databases to find out what are the basics of that product, such as its product code, the optional submission paths and exemptions. Do you need to have a conversation with the FDA through the Q-submission process and if so, what types of questions do you need to ask? The course series uses a college curriculum “101, 102, and Summer School” approach to break down going fairly intricately through how to use the FDA databases, how to interpret them, and then how to draw strategic conclusions from your options.
Why did you decide to get involved with creating this course series and who would benefit from taking it?
I think there are two primary groups of people who are going to find this particular series really helpful. The first group started their career like I did and worked backwards from quality or maybe even design and development from one discipline into the regulatory discipline. They need a primer for fundamental regulatory skills. I think the other group will be those who are new to regulatory affairs in general. I think particularly anybody that's working at a startup or a small to midsize company where you have to wear a lot more hats without in-house mentors. I think both groups would really benefit from this series of coursework.
How did you learn about regulatory pathway assessment?
I just got these jobs where I had to wear that hat and I was the only one doing it. I had to figure it out. So, I'm hoping to kind of circumvent what can be a painful and a trial-and-error process. These courses will really help expedite the learning and help you draw more meaningful conclusions much earlier on.
What are some common challenges that regulatory professionals face when learning about regulatory pathway assessment?
Well, executive management at the startups and the small sized companies can have a lot of trouble coming to terms with what the requirements of their product are, how long it’s going to take, what kind of testing will be needed, and how much money it's going to take. So, I think that crossing that bridge with executive management strategies is one of the biggest and most challenging pieces.
Start learning about regulatory pathway assessment today.
RAPS’ How to Conduct a Regulatory Pathway Assessment Series is available now.
