In this episode of Chasing Compliance, host Jamie Hijmans sits down with John Jolly, a Manager in Global’s Medical Device Department to discuss medical device post-market surveillance (PMS). Over the course of the episode, John and Jamie discuss John’s path from biomechanical engineer to PMS guru, the value of academic research experience in the world of regulatory affairs, what PMS is and why it matters, and the differences between the United States and European Union. Perhaps most importantly, John discusses what the pending European Union Medical Device Regulation (MDR) means for manufacturers in terms of PMS, and he provides a brief overview of 7 aspects of PMS that are going to be affected by the beefed-up regulations. On the lighter side, John and Jamie wrap up the episode with recurring segment, Favorite Friday Nights. John talks about movie night with his family and how working from home has improved his quality of life.
This episode is Part 2 of a two-part episode on Abbreviated New Drug Applications (ANDAs). We continue our conversation with our ANDA expert Sandra...
We are excited to announce the launch of the official Global Regulatory and Consulting Blog. To celebrate the release of the first blog posts...