Experience
We have learned a lot about appropriate use and risk management over the past 8 years and want to share some of that with you. Our experiences have ranged from developing REMS strategies and designing and documenting REMS programs to preparing for implementation and ongoing program operations and assessment. In doing so, we combine our insights into what is doable in clinical practice with what regulators expect for approval and what companies can implement and manage to find the "balance of interests" that is critical for REMS success. The pages in the section provide resources you can use to learn more about who we are and what we do.
- Blogs
- Sharing some of our latest observations, thinking and strategies as we navigate and shape the emerging discipline with our clients
- Webinars
- Information and video from webinars we have hosted or participated in and a schedule of upcoming webinars
- Video / Podcasts
- Video and audio clips from some of us about our approach and methodologies used in pharmaceutical risk management and appropriate use.
- Books / Publications
- Published textbooks on risk management available from the ParagonRx Book Store, and other publications we have authored
- Presentations
- Some online versions of presentations we have made at industry events
- White Papers
- Documents that relate what we have learned and have had success with for those seeking help with "how to" design and implement REMS programs, appropriate use programs and effective educational interventions
- Comments to the FDA
- Comments and presentations ParagonRx has made to public hearings and public meetings held by the FDA
- Testimonials
- Often, the best indicator of what it will be like to work with us comes from the words and experience of those who already have.
- FAQs
- Our responses to questions we are often asked
- Surveys
- There is a lot happening in our industry. We want to know what you think.
