Principles of Pharmacovigilance

Understand the principles of pharmacovigilance

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9 - 11 Dec 2024

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On location

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English

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20,100 DKK ex VAT

(app. 2,702 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

This three day 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.


Other course participants say

"Very informative presentations, which provided a great overview of different PV aspects. As someone who has mainly been introduced to handling of ICSRs at affiliate level, this course has been really good! I have definitely been motivated to learn even more about the different areas in PV. I especially want to praise the course leader, e.g. for sharing her experiences and thoughts. The course was well-executed with a good structure really good lecturers."

Nikoline Hvam, Pharmacovilgilance Specialist, Viatris ApS



"The course was very informative and useful. I learned a lot even though I have worked with PV for several years. A lot of new knowledge."

Camilla Stenkvist Brinth, Safety Officer, Novo Nordisk Denmark A/S


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Keywords

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

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Course leader & lecturers

  • Mette Stie Kallesøe
    Course leader
    Head of Pharmacovigilance QPPV
    Hansa Biopharma AB
  • Charles Cowdale
    Lecturer
    Senior Safety Surveillance Advisor
    LEO Pharma A/S
  • Søren Nilaus Præstegaard
    Lecturer
    PV Compliance Principal Specialist
    Novo Nordisk A/S
  • Mette Skov Meldgaard
    Lecturer
    Specialist Compliance & Process Manager
    Ferring Pharmaceuticals A/S
  • Karsten Lollike
    Lecturer
    Director
    Novo Nordisk A/S
  • Christina Guiton
    Lecturer

    PharmAdvice ApS
  • Maria Oxenbøll
    Lecturer
    Consultant
    Novo Nordisk A/S
  • Atheline Major-Pedersen
    Lecturer
    Safety Surveillance Principal Specialist, Global Safety
    Novo Nordisk A/S
  • Line Michan
    Lecturer
    Director of Department for Pharmacovigilance
    Danish Health and Medicines Authority
  • Karin Erneholm
    Lecturer
    Senior Advisor, PRAC alternate
    Lægemiddelstyrelsen
  • Anne Førrisdahl Steen
    Lecturer
    Safety Surveillance Medical Writing Specialist
    Novo Nordisk A/S
  • Joakim Stokholm Fleinert
    Lecturer
    Safety Data Associate
    Novo Nordisk A/S
See all

Watch the video

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 9 Dec 2024
9 Dec 2024 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
10 Dec 2024 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
11 Dec 2024 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

16 Jan 2025 10:00-13:00
Go to exam page

Registration

Registration deadline
2 Dec 2024
Atrium
Lersø Parkallé 101
2100 København Ø
Registration deadline expired
Sometimes things change. This is the expected programme.

Course information

Literature

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. 

Prerequisites

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.

Examination

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.

Read more

Course leader

Mette Stie Kallesøe
Head of Pharmacovigilance QPPV
Hansa Biopharma AB

Lecturers

Charles Cowdale
Senior Safety Surveillance Advisor
LEO Pharma A/S
Søren Nilaus Præstegaard
PV Compliance Principal Specialist
Novo Nordisk A/S
Mette Skov Meldgaard
Specialist Compliance & Process Manager
Ferring Pharmaceuticals A/S
Karsten Lollike
Director
Novo Nordisk A/S
Christina Guiton

PharmAdvice ApS
Maria Oxenbøll
Consultant
Novo Nordisk A/S
Atheline Major-Pedersen
Safety Surveillance Principal Specialist, Global Safety
Novo Nordisk A/S
Line Michan
Director of Department for Pharmacovigilance
Danish Health and Medicines Authority
Karin Erneholm
Senior Advisor, PRAC alternate
Lægemiddelstyrelsen
Anne Førrisdahl Steen
Safety Surveillance Medical Writing Specialist
Novo Nordisk A/S
Joakim Stokholm Fleinert
Safety Data Associate
Novo Nordisk 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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