I have a passion for safeguarding human and animal health. I have more than a decade of global vigilance experience, and I am committed to working to develop creative solutions to efficiently meet global compliance standards and surveillance needs.
Academic Professional Associate
I have an extensive background in GxP computer validation and change management, and I have a passion for developing talent and driving innovation.
I have a passion for motivating people to explore beyond their comfort zones, think outside the box, and develop creative solutions. There are a variety of ways to approach a situation in Regulatory Affairs. It is rewarding to teach students basic concepts and then watch their creativity bloom as they take chances and collaborate with their classmates to come up with innovative ideas.
What interests me most about Biomedical Regulatory Sciences is Pharmacovigilance and Drug Safety and how it is a unique niche within Regulatory Sciences. It is the juxtaposition of structured requirements and the art of data analysis. In the post-approval space particularly, we have access to ever-expanding data; but the way that this data is managed and interpreted is critical to human and animal health. As regulations, statistical methods, and technology evolve, we are presented with new opportunities.
I am currently pursuing research in two areas. Experience leads to two things – information to share and more questions. In Pharmacovigilance in particular, there is always the inevitable “yeah, but…” when evaluating data. I look forward to engaging students to answer questions and spark new ones.
I hope students come away from my classes with the understanding that to be successful in Regulatory Affairs you must first understand the regulatory framework and must also possess the creativity to extrapolate and create innovative solutions to meet the evolving challenges in the bio-medical field. I would feel successful if they completed the class enthusiastic to apply what they learned and empowered to face the exciting opportunities this field offers.
My hobbies include spending time with my husband and three children and our dawg “Herschel”, hiking, exploring new cuisine, and networking at every opportunity.
Learn more about Kristen Mandello