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Pharmacovigilance for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT-Ps)


Eu2P Short Course: Pharmacovigilance for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT-Ps)

OBJECTIVES

This course intends to provide you with:

  • Overview and classification of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)
  • HCT/Ps development and regulatory requirements
  • Overview of Current Good Tissue Practice (CGTP) and additional requirements for manufacturers of HCT/Ps
  • Overview of FDA’s regulatory approvals process and safety monitoring requirements for HCT/Ps
  • Applications of FDA guidance documents and most recent policies/ updates for regenerative medicine and  stem cell technologies in pharmacovigilance 
  • Strategies on investigating and reporting adverse reactions related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
  • Applicable good manufacturing and good laboratory practices
  • Product labeling, marketing and advertising
  • Considerations for post-licensure requirements and safety reporting 

HCT/P, development, regulatory, guidelines, requirements, CGTP, safety monitoring, FDA

 

LEARNING OUTCOMES

At the end of this course, you should be able to:

  • Become familiar with different types of HCT/P products and select safety monitoring strategy based on streamline approach and primary mode of action

  • Acquire knowledge on Current Good Tissue Practice (CGTP) and additional requirements for manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) as it can contribute to safety of these products due to their specific nature

  • Identify applicable regulations and guidelines for safety management throughout lifecycle of human cells, tissues and cellar and tissue –based products

  • Develop adverse event reporting systems based on current regulatory guidelines and requirements

  • Develop and effectively implement postmarketing safety reporting strategy for HCT/Ps products

 

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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