Principles of Pharmacovigilance, module 1

Understand the principles of pharmacovigilance

10 - 12 Oct 2023

On location


19,550 DKK ex VAT

(app. 2,628 EUR ex VAT)



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.


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


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Course leader & lecturers

  • Anette Kirstine Stark
    Course leader
    MD PHD
  • Mette Stie Kallesøe
    Course leader
    Senior Principal Professional, Deputy QPPV
    LEO Pharma A/S
See all

Is this course for you?

Whether you are new to the field or have several years of experience, this programme is relevant if you are a pharmacovigilance professional who wants to improve your knowledge and skills.

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

Course calendar

Starting 10 Oct 2023
10 Oct 2023 9:00-16:00

Day 1

  • Overview and introduction to international legislation and organisations
  • History and background of pharmacovigilance EU legislative process
  • Current EU pharmacovigilance legislation and guidance
  • EU Organization: EMA, CHMP, PRAC, CMD(h), National Competent Authorities, Efpia, ICH
11 Oct 2023 9:00-16:00

Day 2

  • Introduction to pharmacovigilance quality systems, audits and inspections
  • Introduction to the Pharmacovigilance Systems Master File
  • Introduction to safety in clinical trials • Responsibilities of the Qualified Person for Pharmacovigilance (QPPV)
  • Individual Case Safety Reports (ICSRs) and case processing
  • Workshop on Individual Case Safety Reports
12 Oct 2023 9:00-16:00

Day 3

  • Introduction to Periodic Safety Update Reports (PSURs)
  • Introduction to safety surveillance
  • Introduction to Risk Management Plans (RMP)
  • Introduction to pharmacovigilance related studies
  • Trends and challenges in pharmacovigilance
Practical information

Related exams

27 Oct 2023 9:00-12:00
Go to exam page


Registration deadline
3 Oct 2023
Lersø Parkallé 101
2100 København Ø
10 - 12 Oct
Sometimes things change. This is the expected programme.

Course information


Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

Please familiarize yourself with the mandatory readings before starting the course.

The mandatory readings are also part of the examination syllabus. 


To enroll in this course, you must have a relevant educational background at bachelor level and, as a minimum, two years of experience in drug safety or pharmacovigilance, or other equivalent qualifications. We consider all applications upon registration.

If you do not fulfill the requirements, you can still apply for the course if you have suitable experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 10% of the positions on our course are filled by applicants who have no or limited experience in drug safety or pharmacovigilance. We consider applicants on a case-by-case basis.


The exam is held online, usually 4-6 weeks after the course.

You will receive a link with exam questions via your personal Atrium log-in.

In order to participate in the exam, you must have attended the course.

This course is a part of a diploma

Diploma in Pharmacovigilance

The demand for qualified pharmacovigilance professionals is high. Become a sought after and highly valued professional by attending our pharmacovigilance training and acquire the Diploma in Pharmacovigilance.

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Course leaders

Anette Kirstine Stark
Mette Stie Kallesøe
Senior Principal Professional, Deputy QPPV
LEO Pharma A/S

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Want to know more or need help?

Contact Educational Programme Leader Lone Rex at +45 20 62 11 46

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