June 19, 2020
Noon - 1:00 p.m.
SOCRA NYS CHAPTER SUMMER WEBEX SERIES (FREE)
Friday, June 19
Noon – 1:00 p.m. EST
Risk Evaluation and Mitigation Strategy (REMS) and Beyond
Kayt Marra, MA, CD-N, CCRP, Section of Genetics & Metabolism, Albany Medical Center
Risk Evaluation and Mitigation Strategy or REMS is a drug safety program that the U.S. Food and Drug Administration can require drug manufacturers to initiate for certain medications with serious safety concerns. The goal of REMS is to ensure the benefits of the medication outweigh its risks by providing additional education that will promote safe use. However, REMS is only the very beginning of an ongoing education process. When members of the target population may have some cognitive impairment related to the condition additional steps need to be taken. This presentation will provide an overview of PKU and Palynziq the newest medication to treat the condition, the limitations of the medication, a review of the REMS, and additional steps taken by the manufacturer and our facility to safeguard patients using this medication.
This program is open to the public, anyone may attend this free Zoom webex.
As many of our attendees access continuing education for their professional certifications, please note when you register if you need a Certificate of Attendance and whether you are a SOCRA member.
You must register to attend. Send registration request to: firstname.lastname@example.org
Once registered, Zoom access information will be provided.
SOCRA continuing education approved for 1 hour for this program. SOCRA accepts documentation of candidate participation in continuing education programs for re-certification for programs applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.