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Pharmacovigilance in Combination Products and Regulations


Eu2P Short Course: Pharmacovigilance in Combination Products and Regulations

OBJECTIVES

This course intends to :

  • Give with a brief overview of types of combination products and the final rule to define their “primary mode of action” (PMOA)
  • Review of current laws, regulations and guidelines for combination products
  • Description of principles of risk‑based quality and safety management for combination products
  • Strategy on how to develop relevant metrics as quality and performance indicators for risk-based quality management (RBQM) pharmacovigilance systems, while developing combination products
  • Framework for identifying safety signals and developing management strategy based on current regulatory requirements
  • FDA’s Final Rule for postmarketing safety reporting for combination products

laws, regulations, guidelines, combination products, quality, strategy, RBQM, framework, safety signals, FDA

 

LEARNING OUTCOMES

At the end of the course, you will :

  • Know the different types of combination products and select safety monitoring strategy based on streamline approach and primary mode of action

  • Identify applicable regulations and guidelines for safety management throughout lifecycle of combination products

  • Develop and effectively implement postmarketing safety reporting strategy for combination products

  • Develop adverse event reporting systems based on Compliance Policy for combination product postmarketing safety reporting

 

180 minutes
Online based learning
English language
Certificate of Achievement
300 € / $350
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AUTHORS

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Dr. Marina Malikova

Executive Director of Research
Boston University School of Medicine

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Nasop Experts Group

ISoP's North American chapter




COMPANIES OFFER

Short courses can be included in a training package for your team!


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