Overview
Special Instructions: Please bring your own laptop.
Learn about the fundamentals of clinical drug safety and the key tools available for postmarketing pharmacovigilance. Discuss the application and inter-relationships of these tools, and consider future directions for the field. Gain knowledge of the latest changes in the US and EU regulations and best practices for compliance. Develop an in-depth understanding of the requirements and procedures that must be performed to protect patient safety and to remain in compliance with legal obligations in two key regulatory jurisdictions. Didactic presentations will be supplemented with case studies and practical exercises to reinforce learning. There will be ample time for Q&A with faculty.
Course Level: Intermediate
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