LIVRO Navigating Regulatory Guidelines (English Edition) PDF Mark Stinson

In this book, I’ll present views on navigating regulatory guidelines for drug advertising and promotion. These viewpoints are from my role as a brand innovator. The talk was part of a graduate course in Applied Clinical and Preclinical Research, part of an interdisciplinary curriculum in the Colleges of Nursing, Pharmacy, and Medicine at The Ohio State University.– First, I will share with you the basis for commercialization strategies I’ve seen pharma and medical device companies use. — Then, I’ll share lessons learned from seven relevant cases.I chose the illustration of an Idaho river and rafters to illustrate the idea of navigating regulatory guidelines, because I believe that there are ups and downs in the process – some calm waters and some choppy, white waters all through the process. If you learn to navigate them then you can have a successful medical promotional experience.My observations as a brand innovator come from developing and working on brand strategies for over 100 product launches and re-launches. I’ve worked in a wide range of categories on pharma, biotech, devices, and diagnostics. During that time, I facilitated cross-functional teams that have very often included the medical, regulatory, and legal representatives of the team, in addition to the marketing, advertising, and sales teams. I’ve also personally negotiated promotional claims with DDMAC and now OPDP on behalf of my clients. The cases and experiences I’ll share with you are from my own firsthand experience.