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 to create our new RAPS Online University course series: 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. It emphasizes that all medical device products can go through these steps to reach commercialization and focuses on how to submit various presubmission types to FDA and special considerations for their use.
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 Lean RAQA. We help small to midsize companies navigate their regulatory pathway requirements through their submissions and into their quality management systems. I have worked with RAPS in several different capacities, but most recently on creating a series on educating people on how to do the regulatory pathway assessment process from the ground up.
How to Conduct a Regulatory Pathway Assessment Series: FDA 101 is available today. Learn more about this course series here.
What is regulatory pathway assessment and why do regulatory professionals need to know about it?
Regulatory pathway assessment is really the building block of a regulatory strategy. So, any time you have a new product or modifications to a product or an intended use, you need to scavenge the FDA databases to find out what are the basics of that product, what are its product code, what are the optional submission paths and strategies? Do you need to have a conversation with the FDA through the Q-submission process? What types of questions do you need to ask?
The course series covers that: the basics, broken down and almost a “101, 102 and some are extra credits” approach, and it goes fairly intricately through how to use the FDA databases, how to interpret them, and then how to draw strategic, strategic conclusions from what your options are.
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. And 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 some more of those fundamental skill sets.
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 and where you also don't have very many mentors in-house. 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 process 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, how what kind of testing, 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 today.