Principles of Pharmacovigilance

Understand the principles of pharmacovigilance

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3 days course

English

17.350,- DKK ex VAT
(app. 2.333,- EUR ex VAT)

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Module 1

Summary

This course will help you understand the principles of pharmacovigilance, including factors such as Adverse Drug Reactions (ADRs), pharmacovigilance legislation and regulations, the methods used to collect and evaluate adverse drug reactions, preferred communication channels when communicating with authorities and the ethical considerations and implications of pharmacovigilance.

You will be introduced to suspected unexpected serious adverse reactions (SUSARs), individual case safety reports (ICSRs), periodic safety update reports (PSUR) and development safety update reports (DSUR), product safety information and signal detection, quality systems and pharmacovigilance audits and inspections.

The course is offered every 2 years.

Keywords

Pharmacovigilance Legislation
Safety Data
Post-Authorization Safety Studies (PASS)
Risk Management Plans (RMP)
Pharmacovigilance Evaluation
Pharmacoepidemiology
Communication

What you will learn

  1. The principles of pharmacovigilance
  2. How to analyze and evaluate methods and data in drug safety reporting
  3. How to analyze and evaluate regulations and guidelines in pharmacovigilance
  4. Best practices in pharmacovigilance working processes when preparing safety assessments and reports
  5. How to design appropriate pharmacovigilance working methods in a dynamic and changing environment

What your company will get

  1. A safety and pharmacovigilance professional who understands the principles of pharmacovigilance
  2. A safety and pharmacovigilance professional that 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
  4. An employee who can provide valuable input to all other team members involved in pharmacovigilance working processes

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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This course is a part of this programme

Pharmacovigilance Diploma

An international training programme ... Read more

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Client Manager Ida Salicath at +45 39 15 09 46

Send an email

 

 

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