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OVERVIEW
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;
·Hear regulators and industry representatives from around the world explain RMPS as they apply to medicinal products, therapeutic biologics, and vaccines, and how a harmonized RMP can promote efficient, evidence-based decision making to support the best use of marketed products and thereby enhance public health;
·Participate in hands-on exercises to develop a harmonized approach to creating an RMP for a fictitious product; and
·Interact with experts from competent authorities and marketing application holders during hands-on sessions, extensive Q&A, and in-depth panel discussions.
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