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Gene therapy


Eu2P Short Course: Gene therapy

OBJECTIVES

This course aims to review the current pharmacovigilance requirements for Gene Therapy

  • Clinical development and long-term follow-up
  • Pharmacovigilance complexities with regard to different type of Gene Therapy as described within FDA guidance
  • Understand EU perspective for development of ATMP
  • High level understanding of ethical consideration

Gene, therapy, FDA guidance, ATMP, ethic

 

LEARNING OUTCOMES

At the end of the course, you will be able to understand the view of the US regulators on Gene Therapy and EMA perspective of the advance therapies. In addition, it will provide you with an understanding on Pharmacovigilance and ethical complexities associated with them.

 

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

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Nasop Experts Group

ISoP's North American chapter

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Dr. Sepideh Habibi

Global Head of Pharmacovigilance and Risk Management
CRISPR Therapeutics




COMPANIES OFFER

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


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+33 6 30 29 00 29

Monday-Friday / 9.00am-6.00pm CET

 

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