2 new opportunities for regulatory professionals to learn online, created by regulatory professionals
With the launch of two new online courses, the Regulatory Affairs Professionals Society has new opportunities for regulatory professionals to deepen their knowledge in regulatory writing and regulatory pathway assessment.
With these two new courses and an update to a course on European medical device regulations, RAPS Online University now offers more than 50 courses across the topical areas of regulatory essentials, medical devices, pharmaceuticals, quality and clinical. Here’s what to know about each of these two new courses.
New course: Regulatory Writing: Building a Successful Culture for Collaborative Writing
Regulatory professionals must translate information from various scientific disciplines, first onto the written page and ultimately to regulatory authorities. That requires teamwork. This course explores the barriers to effective teamwork on interdisciplinary teams, along with identifying strategies for timely, relevant, and understandable communication.
“Collaboration is always important, but in an age where more and more people are working remotely, increased attention needs to be paid to the means of building good working relationships at a distance,” says Hofstra University Associate Professor of Writing Studies and Rhetoric Lisa DeTora, who helped develop the course.
New course: How to Conduct a Regulatory Pathway Assessment Series: FDA 101 Navigating the FDA for the first time
The first in a series of three courses, this is an introduction to the regulatory world of medical devices. It gives the user an overview of the FDA organization and the importance of a well-defined regulatory strategy. This first course introduces FDA risk-based device classifications, FDA product codes, regulatory controls, and the five steps to market for a new medical device. The next two courses in this series are expected this summer.
“It’s the foundational skill with everything else will build upon,” says Lean RAQA Principal and Founder Michelle Lott, who helped develop the course. “This course introduces new regulatory professionals to idea of regulation as a strategy. It emphasizes that all medical device products can go through these steps to reach commercialization.”
Build your regulatory knowledge and advance your career
Certificates and courses from RAPS Online University help regulatory professionals around the world to take the next step in their educational journey. Self-paced, customizable certificate programs allow regulatory professionals to personalize their education to fit their educational needs — and their life.
Other upcoming RAPS Online University courses releasing later this year include a series on safety and performance in the MedTech industry.