GET CERTIFIED IN DRUG SAFETY


RECOGNIZED COURSE QUALITY


DESIGNED FOR EXPERTS BY EXPERTS


Aggregate reporting in the US


Eu2P Short Course: Aggregate reporting in the US

OBJECTIVES

The analysis of the safety profile of any medicine should weight up the consequences of a given adverse drug reaction to individual patients exposed to the medicine, as well as the impact on the community.

This course intends to bring you :

  • Information relating to types of aggregate reporting in pharmacovigilance
  • Knowledge of US aggregate reporting requirements

aggregate, reporting, requirements, PADERs, PAERs, DSURs, PSURs

 

LEARNING OUTCOMES

At the end of the course, you will have :

  • Knowledge of aggregate reports, including Periodic Adverse Drug Experience Reports (PADERs) and Periodic Adverse Experience Reports (PAERs), as well as Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs) as applicable to FDA requirements

  • Knowledge of the US Regulatory Framework

 

150 minutes
Online based learning
English language
Certificate of Achievement
250 € / $290
REGISTER NOW

AUTHORS

avatar

Dr. John Price

Pharmaceutical physician consultant, patient safety, pharmacovigilance and regulatory affairs
Independent

avatar

Nasop Experts Group

ISoP's North American chapter




COMPANIES OFFER

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


NEED TO TALK TO US?

+33 6 30 29 00 29

Monday-Friday / 9.00am-6.00pm CET

 

Powered By

Eu2P Executive Board partners

Created By

Eu2P project consortium partners