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Overview

Short Course* Registration: 8:00AM-5:00PM


The instructors for this short course draw on experience from both direct involvement in the development of the ICH guideline itself, as well as from experts with extensive experience in actual implementation. This short course will cover the background and expectations behind key sections of the guideline and will provide an in-depth interpretation from the perspective of the expert working group that developed the concept. Based on this theoretic foundation, the course will then move to more practical aspects of implementation and lessons learned from experience since the PBRER format was first introduced. This will include the latest thinking and updates from the EU. The intent of this course is to be interactive and to tailor to your needs as much as possible. Questionnaires will therefore be sent to you to assess expectations based on level of experience as well as any key questions you wish the instructors to specifically address with the aim that answers are developed together in a coaching environment.

*Short Courses are not included in the conference registration and require a separate fee.

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Learning objectives

At the conclusion of this short course, participants should be able to:

  • Discuss the main principles defined in the ICH E2C(R2) guideline
  • Describe the structure and content of the new PBRER
  • Explain the regulatory authority expectations of the PBRER
  • Recognize how to implement the PBRER to encompass multiple functions
  • Discuss and evaluate the practical aspects in the preparation of the PBRER

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Pharmacovigilance Inspections Part 2: Response, Measurement, Resolution, and Tracking


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Pharmacovigilance and Risk Management Strategies Conference