Pharmacoepidemiology and Post-Authorisation Safety Studies

Learn the essentials of pharmacoepidemiological methods and data sources for post-approval studies (PASS)
No available dates

On location

English

30,000 DKK ex VAT

(app. 4,033 EUR ex VAT)

Summary

This accredited course (ECTS 5), offered in collaboration with University of Copenhagen, covers the principles of pharmacoepidemiology, data sources, post-approval safety studies (PASS) and related international legislation and guidelines. The regulations, practices and processes related to PASS are also included, covering both the pharmaceutical industry and the role of the regulatory authorities (EMA, PRAC and CHMP, FDA).

At the course, you will acquire an understanding of the different types of evidence produced by pharmacoepidemiological studies of adverse drug effects, and of the strengths and weaknesses of different study designs and methods. Additionally, you get a basic understanding of how to apply these skills in pharmacovigilance and risk management.

After completing the course, you will be able to choose the design and data sources that best fit the purpose of a given study and to critically evaluate published literature on drug safety. You will also know how to integrate results from drug safety surveillance.

At the course, lectures are supplemented with group discussions based on real and simulated safety scenarios and scientific literature. Prior to the course there will be some online theory exercises.

This course is an elective course for students at University of Copenhagen's Master of Industrial Drug Development (MIND). The course is open to single course students and students from other master's programmes. 
 

Key words


PLEASE NOTE:

As this course is offered in collaboration with the University of Copenhagen, you apply via the joint Atrium and University of Copenhagen application form. This means that you will be enrolled at both Atrium and the University of Copenhagen, and that your data will be registered at both institutions. If you are not enrolled as a master student, you will be registered as a single course student at the University of Copenhagen.

Course fee includes examination. By default, you pay the full amount to the University of Copenhagen regardless of whether you take the exam or not. If you decide not to take the exam, you can apply for a refund of the exam fee by contacting Atrium – please see contact details below. You must apply for a refund no later than two weeks after completion of the course.


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Course leader(s) & Lecturer(s)

  • Morten Andersen
    Course leader
    Professor in Pharmacovigilance
    University of Copenhagen
  • Betina Østergaard Eriksen
    Course leader
    Vice President Safety Surveillance
    Novo Nordisk A/S
  • Jesper Hallas
    Lecturer
    Professor in Clinical Pharmacology
    Syddansk Universitet
  • Atheline Major-Pedersen
    Lecturer
    Safety Surveillance Principal Specialist, Global Safety
    Novo Nordisk A/S
  • Per Sindahl
    Lecturer
    Safety officer
    Lægemiddelstyrelsen
  • Marcus Schartau
    Lecturer
    Safety Surveillance Risk Management Specialist
    Novo Nordisk A/S
  • Janne Petersen
    Lecturer
    Head of Copenhagen Phase IV Unit and Section for Data, Biostatistics and Pharmacoepidemiology
    Region Hovedstaden
  • Stine Hasling Mogensen
    Lecturer
    Videnskabelig chefkonsulent
    Lægemiddelstyrelsen
  • David Dore
    Lecturer
    Principal Scientist
    Exponent
  • Tine Kvist
    Lecturer
    Scientific Vice President
    Novo Nordisk A/S
  • Francesca Blythe
    Lecturer
    Senior Managing Associate
    Sidley Austin LLT
  • Lene Hammer-Helmich
    Lecturer
    Director, Real World Evidence&Epidemiology
    H. Lundbeck A/S
  • Lars Christian Lund
    Lecturer
    Clinical Pharmacology
    Syddansk Universitet
  • Mia Aakjær
    Lecturer
    Postdoc
    Københavns Universitet
  • Kristoffer Jarlov Jensen
    Lecturer
    Pharmacoepidemiologist
    Copenhagen Phase IV Unit
See all

IS THIS COURSE FOR YOU?

This course is relevant for alle pharmacovigilance professionals, e.g. safety surveillance advisers, safety scientists, and patient safety associates.

What you will learn

  1. How to explain and discuss the pharmacoepidemiological methods used to generate evidence on drug safety.
  2. How to account for central pharmacoepidemiological concepts.
  3. How to understand and discuss the role of PASS in pharmacovigilance and risk management.
  4. How to explain and discuss relevant legislation and guidelines covering PASS.

What your company will get

  1. An employee who is familiar with pharmacoepidemiological evidence and the scientific and regulatory aspects of PASS.
  2. An employee who can critically evaluate published literature on drug safety.

Course information

Literature

The syllabus comprises selected chapters from Strom’s Pharmacoepidemiology, 6th edition, relevant legislation (including EU directives, EMA guidelines), good pharmacoepidemiology practice guidelines, other book chapters, scientific papers and review papers. During the course, further material consisting of lecture handouts, notes, articles, and case studies will be distributed.

Prior to the course you get access to mandatory and optional readings via your personal Atrium log-in. Please familiarise yourself with the mandatory readings before starting the course. The mandatory readings are also part of the examination syllabus.

Prerequisites

Applicants must meet the following criteria:

  • A relevant BA degree or equivalent
  • A minimum of 2 years of relevant job experience

Examination

The exam for this course is a written assignment (3 hours). The examination will be held on “Digital Exam” (the online examination platform of the University of Copenhagen) approximately two weeks after completion of the course. 

Course leader(s)

Morten Andersen
Professor in Pharmacovigilance
University of Copenhagen
Betina Østergaard Eriksen
Vice President Safety Surveillance
Novo Nordisk A/S

Lecturer(s)

Jesper Hallas
Professor in Clinical Pharmacology
Syddansk Universitet
Atheline Major-Pedersen
Safety Surveillance Principal Specialist, Global Safety
Novo Nordisk A/S
Per Sindahl
Safety officer
Lægemiddelstyrelsen
Marcus Schartau
Safety Surveillance Risk Management Specialist
Novo Nordisk A/S
Janne Petersen
Head of Copenhagen Phase IV Unit and Section for Data, Biostatistics and Pharmacoepidemiology
Region Hovedstaden
Stine Hasling Mogensen
Videnskabelig chefkonsulent
Lægemiddelstyrelsen
David Dore
Principal Scientist
Exponent
Tine Kvist
Scientific Vice President
Novo Nordisk A/S
Francesca Blythe
Senior Managing Associate
Sidley Austin LLT
Lene Hammer-Helmich
Director, Real World Evidence&Epidemiology
H. Lundbeck A/S
Lars Christian Lund
Clinical Pharmacology
Syddansk Universitet
Mia Aakjær
Postdoc
Københavns Universitet
Kristoffer Jarlov Jensen
Pharmacoepidemiologist
Copenhagen Phase IV Unit

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

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