Pharmacovigilance Systems Master File

Understand the basic principles of pharmacovigilance systems

  • 19. Sep 2017

3 days course

English

15.500,- DKK ex VAT
(app. 2.084,- EUR ex VAT)

Module 2

Summary

This course will help you understand the basic principles of pharmacovigilance systems and the organization of a pharmacovigilance department and its interfaces with other departments. You will also learn about the standard operational procedures in a pharmacovigilance department and the use of and access to databases, how to prepare and follow up on audits and inspections, and how to operate in a highly dynamic and changing environment.

The course is offered every 2 years.

Keywords

Pharmacovigilance Systems
Interfaces with other departments
Standard Operative Procedures
Medical Dictionary for Regulatory Activities (MedDRA)
Qualified Person for Pharmacovigilance (QPPV)
Periodic Safety Update Reports (PSURs)
Pharmacovigilance Agreements
Inspections and Audits

What you will learn
 

  1. The basic principles of pharmacovigilance systems
  2. The organization of a pharmacovigilance department and its interfaces with other departments.
  3. How to analyze and evaluate methods and data in drug safety reporting
  4. How to evaluate regulations and guidelines in pharmacovigilance and pharmacovigilance systems
  5. Best practices in drug safety reporting, including relevant Standard Operating Procedures (SOPs)

What your company will get

 

  1. A safety and pharmacovigilance professional who understands the principles of pharmacovigilance systems
  2. A safety and pharmacovigilance professional who can independently analyze and evaluate methods and data in drug safety reporting
  3. A safety and pharmacovigilance professional who can analyze and evaluate regulations and guidelines in pharmacovigilance and pharmacovigilance systems
  4. An employee who can play an important role in any project team working with pharmacovigilance systems
Available start dates

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 Carina Schaldemose Hansen, Digital Project Manager at + 45 39 15 09 22, or send her an email at csc@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 on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Programme Director Gitte Hornemann Møller at +45 39 15 09 20

Send an email

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