Pharmacoepidemiology and Post-Authorisation Safety Studies

Learn the essentials of pharmacoepidemiological methods and data sources for post-approval studies (PASS)

30 May 2022

5 days course

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

  • Pharmacoepidemiology
  • Risk management
  • Healthcare databases
  • Evidence
  • Post-authorisation safety studies (PASS)

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
  • Kajsa 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
    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 calendar

Starting 30 May 2022
30 May 2022 9:00-16:00

Day 1

  • Measures of occurrence and effect
  • Cohort Studies
  • Sources of error, bias and confounding
  • Drug utilization studies
  • Workshop: cohort Study
31 May 2022 9:00-16:00

Day 2

  • Analysis of epidemiological studies
  • Basic statistical concepts and interpretation
  • Case-control and other study designs
  • Workshop: case control study
1 Jun 2022 9:00-16:00

Day 3

  • Data sources for post-approval studies
  • Data protection regulation, ethics and confidentiality
  • Multi database studies
  • Effectiveness studies
  • Pragmatic trials, incl. workshop
2 Jun 2022 9:00-16:00

day 4

  • The role of pharmacoepidemiological studies in pharmacovigilance
  • Regulatory processes, legislations, and guidelines
  • The connection between pharmacoepidemiological studies and risk management plan
  • Safety Reporting in PASS studies
  • Workshop: PASS
3 Jun 2022 9:00-16:00

Day 5

  • Authority initiatives for safety analysis using RWD
  • PRAC
  • Use of RWD during the COVID-19 pandemic
  • The framing of pharmacoepidemiology in society
  • Workshop: design a study to evaluate a potential risk
Practical information

Registration

Registration deadline
2 May 2022
Atrium
Lersø Parkallé 101
2100 København Ø
Register
30 May - 3 Jun
Sometimes things change. This is the expected programme.

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. 

Date: 17 June 2022 from 10.00 - 13.00

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
Kajsa Kvist
Scientific Vice President
Novo Nordisk A/S
Francesca Blythe
Senior Managing Associate
Sidley Austin LLT
Lene Hammer-Helmich
Director, Real World Evidence
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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