Introduction to Drug Safety and Pharmacovigilance

Learn the terminology and the basic elements of drug safety and clinical trial safety

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  • 28. Apr 2020
  • 27. Oct 2020

3 days course

English

12.300,- DKK ex VAT
(app. 1.654,- EUR ex VAT)

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Summary

At this course, you will learn the basics about safety and pharmacovigilance in post-marketing surveillance and clinical trials. You will receive a comprehensive introduction to essential terminology and information sources as well as a thorough introduction to why and how clinical trials are performed.

The course also examines regulatory reports such as Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR), product safety information and signal detection, interfaces with regulatory departments and with quality assurance about pharmacovigilance audits and inspections, and how to prepare for these.
  

Keywords

Danish and European Drug Safety Regulations
The Danish Health and Medicines Authority
The Individual Case Report
Electronic Submission
MedDRA
Clinical Trial Directive 2001/20EC
Non-Interventional Trials
Risk Management Plans

Course calendar

Start 28. Apr 2020
28. Apr 2020
29. Apr 2020
30. Apr 2020
Registration deadline 21. Apr 2020
Start 27. Oct 2020
27. Oct 2020
28. Oct 2020
29. Oct 2020
Registration deadline 20. Oct 2020

What you will learn

  1. The basic principles and elements of pharmacovigilance
  2. The essential terminology and information sources
  3. How to use best practices in drug safety and pharmacovigilance working processes
  4. How to prepare adverse event reports and the appropriate pharmacovigilance working methods

What your company will get

  1. A safety and pharmacovigilance professional who understands the basic principles and elements of pharmacovigilance
  2. A safety and pharmacovigilance professional who can operate in a dynamic and changing environment
  3. A safety and pharmacovigilance professional who can provide valuable input to all other team members working with drug safety and pharmacovigilance
Available start dates
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Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at contact@atriumcph.com

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick and cannot attend the course, you may hand over the seat to a colleague, who will then have to register for the course on our website prior to course start. If the registration is closed, please send us full name, email, phone and title of your colleague to bfl@atriumcph.com. Read our cancellation policy.

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WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Client Manager Birger Flinthagen at +45 39 15 09 06

Send an email

 

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