Serialisation – New EU Aide Memoire for GDP
Title: Safety considerations for an Rx to OTC Switch Program
Date: Wednesday, June 12, 2019
Time: 04:00 PM Central European Summer Time
Duration: 1 hour
Summary
Switching a prescription (Rx) product to over-the-counter (OTC) status can be a commercially rewarding option for extending its lifecycle.
A successful Rx-to-OTC switch requires consideration of multiple, potentially complex, factors such as regulatory environment, safety and potential for misuse, product differentiation, and distribution.
One of the most important parts of an Rx-to-OTC switch program is the safety assessment. PharmaLex’s pharmacoepidemiology and drug safety group (PER-EPI) specializes in reviewing safety reports and preparing the safety sections of switch applications.
This webinar will help you to:
- Understand how safety considerations affect the many aspects of an Rx-to-OTC switch program
- Integrate FDA’s principal safety concerns into a switch submission
- Understand how analyses are conducted to support a product’s safety
- Examine how these elements apply in a case study
Bao-Anh Nguyen-Khoa PharmD, MPH
Senior Manager, Pharmacovigilance, Epidemiology & Risk Management (PER-EPI)
PharmaLex US Corporation
Senior Manager, Pharmacovigilance, Epidemiology & Risk Management (PER-EPI)
PharmaLex US Corporation
Bao is a licensed clinical pharmacist with Doctor of Pharmacy (with a residency in Drug Information) and Master of Public Health degrees. He joined PharmaLex (via The Degge Group, Ltd.) in 2003 and is currently a Senior Research Manager with the pharmacoepidemiology and drug safety group (PER-EPI).
In addition to leading multi-disciplinary teams in designing, analyzing, and publishing safety research on prescription and OTC medications for industry clients, he has served as a safety analyst in support of drug litigation. Dr. Nguyen-Khoa also managed a company internship program through which he mentored more than 25 graduate students in the fields of public health, pharmacy, and health outcomes. Prior to joining PharmaLex, Bao was a practicing pharmacist in multiple care settings, which helped him gain insight from the perspectives of the patient, provider, institution, and payer.
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