Discover this podcast and so much more

Podcasts are free to enjoy without a subscription. We also offer ebooks, audiobooks, and so much more for just $11.99/month.

Risk Evaluation and Mitigation Strategy (REMS)

Risk Evaluation and Mitigation Strategy (REMS)

FromQueens of Quality Podcast


Risk Evaluation and Mitigation Strategy (REMS)

FromQueens of Quality Podcast

ratings:
Length:
28 minutes
Released:
Sep 7, 2022
Format:
Podcast episode

Description

Join in another fantastic episode with your hosts, Jennifer and Michelleanne. In today’s episode, we talk about Risk Evaluation and Mitigation Strategy (REMS). We talk about the history of Thalidomide and why REMS closely monitors it. Moreover, we discuss the different pieces of REMS and the difference between Single REMS & Shared REMS.Additionally, we talk about the difference between Pharmacovigilance (PV) & REMS, The REMS Industry Consortium (RIC), and how to get started with a REMS program. Tune in! During this episode, you will learn about;[00:30] Episode introduction[00:37] Today’s theme; Risk Evaluation and Mitigation Strategy (REMS) [01:18] When was REMS started?[01:44] The history of Thalidomide and why REMS closely monitors it[07:03] Single REMS vs Shared REMS [11:20] Risk piece in REMS program [12:21] Evaluation piece in REMS program [17:35] The difference between Pharmacovigilance (PV) and REMS[18:35] Mitigation piece in REMS program [21:44] The REMS Industry Consortium (RIC) [25:28] How to get started with a REMS program[26:55] What to expect in the next episode[27:41] How to connect with us  Remember to Subscribe, Rate, Review, Like, and Share!Let’s Connect!Website: https://metisconsultingservices.com/LinkedIn: https://www.linkedin.com/company/metis-consulting-services/Email: info@metisconsultingservices.com
Released:
Sep 7, 2022
Format:
Podcast episode

Titles in the series (19)

Quality and compliance are often seen as rigid within an organization. Every company has ‘em; nobody wants ‘em, but it’s even more imperative to implement them. Join, Michelleanne and Jen, host of Queens of Quality, the podcast, as they discuss topics in reasonable and, at times, light-hearted delivery. Receive insight on how these requirements can be implemented in a compliant, scale-able, and sustainable manner for organizations at any point within the company life cycle. Every week, we will provide solutions for day-to-day issues to debunk some of the misconceptions about Quality Assurance. Subscribe to the show to stay up to date with new episodes.