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!