Are you interested in making the leap from regulatory zero to marketing hero? The key to building a successful medical device business is finding balance between meeting regulatory requirements and maximizing marketing opportunities. It is critical that life science professionals understand the role of regulatory affairs and its impact on revenue generation. This course uses case studies (e.g. labeling 483s, DOJ settlements), class discussions and research to cover the essentials of medical device marketing in the U.S.
This course is designed to help you:
- Learn the ins and outs of the FDA and other government controls that regulate device marketing activities and communications.
- Discover why labeling claims influence market and clinical opportunities—and why it is essential to collaborate with marketing before final labeling claims are submitted.
- Learn how to advise marketing on how to maximize the use of approved labeling.
- Gain a better understanding of how digital marketing can be used in demand generation, including the fast-paced social media environment.
- Master the art of constructing compliant social media engagement guidelines through collaboration with your marketing department.
Coursework will include reading assignments, class presentations, quizzes and midterm and final projects.
This course is intended for regulatory and compliance professionals, marketing executives, product managers, research and development and engineers who interact with marketing and communications professionals. The course focuses on a proactive, collaborative approach to support a medical device in achieving strategic business objectives while maintaining compliance.