GET CERTIFIED IN DRUG SAFETY


RECOGNIZED COURSE QUALITY


DESIGNED FOR EXPERTS BY EXPERTS


PRE-MARKETING PHARMACOVIGILANCE LEGISLATION


OBJECTIVES

This course aims to give you knowledge of pre-marketing pharmacovigilance legislation in the European Union.

This course firstly deals with the EU Regulatory framework governing drug safety during clinical trials (briefly mention FDA):

  • Definitions, Adverse Reaction Reporting (ICH E2A)
  • Overview of Good Clinical Practice

Then, with development Safety Update Reports (ICH E2F).

ICH, Good Clinical Practice, EU Legislation, Regulatory Framework, PV, IND

 

LEARNING OUTCOMES

At the end of this course, you will be able to understand the legal framework that governs the pre-authorisation phase including efficacy aspects Clinical Trial Assay authorisation, Investigational New Drug, approval for studies & Good Clinical Practice.

 

60 minutes
Online based learning
English language
Certificate of Achievement
500 €
REGISTER NOW

AUTHOR

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Dr. Sherael Webley

University of Hertfordshire



COMPANIES OFFER

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


NEED TO TALK TO US?

+33 5 47 30 42 69

Monday-Friday / 9.00am-6.00pm CET

 

Supported By

IMI logo EU logo efpia logo

Created By

Eu2P Partners