THIS MEETING HAS BEEN POSTPONED. WE ARE WORKING TO IDENTIFY A NEW DATE AND WILL POST IT TO THE DIA WEBSITE WHEN IT S CONFIRMED.
RMPs and REMS: Global Regulators Guide Hands-on Workshop
This conference will teach you how to identify and organize essential components of an RMP vis-á-vis well-described risks, poorly understood risks, and certain potential risks of products, which may be made available to patients and healthcare providers in different regions of the world. It includes hands-on exercises in addition to didactic presentations, interactive examples, and panel discussions.
CONFERENCE HIGHLIGHTS
· Learn why risk management plans (RMPs) are important to your organization from a global regulatory perspective and the pros and cons of a global vs. local approach to developing RMPs;
Learning Objectives:
At the conclusion of this conference, participants should be able to:
· Discuss the fundamental aspects of RMPs as applied to medicinal products, therapeutic biologics, and vaccines;
· Recognize similarities and differences in RMP requirements in several regulatory jurisdictions, including Canada, the European Economic Area, Japan, and the US; and
· Discuss the role of RMPs from the perspective of marketing authorization holders, regulatory authorities, and other stakeholders.
Target Audience:
This conference is designed for professionals with basic to intermediate levels of experience in pharmacovigilance and risk management and who are responsible for developing and evaluating RMPs, generating and assessing drug safety signals, and organizing postauthorization safety studies.
Event Code:
09014
Contact Information:
Event information: Contact Ellen Diegel at the DIA office by telephone +1-215-442-6158, fax +1-215-442-6199 or email Ellen.Diegel@diahome.org.