Introduction to Drug Safety and Pharmacovigilance

Learn the terminology and the basic elements of drug safety and clinical trial safety

1 - 3 Nov 2023

or

27 - 29 May 2024

On location

English

19,600 DKK ex VAT

(app. 2,635 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

At this course, you will learn the basics about safety and pharmacovigilance in post-marketing surveillance and clinical trials. You will receive a comprehensive introduction to essential terminology and information sources as well as a thorough introduction to why and how clinical trials are performed.

The course also examines regulatory reports such as Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR), product safety information and signal detection, interfaces with regulatory departments and with quality assurance about pharmacovigilance audits and inspections, and how to prepare for these.


Other course participants say

"I enjoyed the variety of lectures and the great presenters. The whole experience was very rewarding for me. I loved the structure of topics; it was easy and interesting to follow. I made very useful notes, and I am very sure I will use the provided slides in my future work."

Sabina Kujundzic, Pharm. D., Safety Data Associate, H. Lundbeck A/S 


"The course had very good speakers, a nice venue, friendly atmosphere, and a good mix of relevant topics."

Anna Wanland, Market Access Manager, AcuCort AB


Keywords

  • Danish and European Drug Safety Regulations
  • The Danish Health and Medicines Authority
  • The Individual Case Report
  • Electronic Submission
  • MedDRA
  • Clinical Trial Directive 2001/20EC
  • Non-Interventional Trials
  • Risk Management Plans

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Course leader & lecturers

  • Mette Philipsen
    Course leader
    Cluster Safety Lead
    Pfizer ApS
  • Berit Nautrup Andersen
    Lecturer
    Lead Specialist - QMS, Training and PV Intelligence
    H. Lundbeck A/S
  • Claudia Pierleoni-Nielsen
    Lecturer
    Director, Head of Safety Surveillance, Global Safety
    Leo Pharma A/S
  • Jannik Høvring Nielsen
    Lecturer
    Safety Surveillance Principal Specialist, Global Safety
    Novo Nordisk A/S
  • Jeannett Dimsits
    Lecturer
    Partner
    InnoStrat ApS
  • Kishore Saha
    Lecturer
    Chief Specialist - Global Patient Safety
    H. Lundbeck A/S
  • Line Alleslev Larsen
    Lecturer
    Senior Pharmacovigilance Specialist
    KLIFO A/S
  • Mette Stie Kallesøe
    Lecturer
    Head of Pharmacovigilance QPPV
    Hansa Biopharma AB
  • Morten Gaardlykke
    Lecturer
    Head of Regulatory Affairs Denmark & Iceland
    Pfizer ApS
  • Peter Eriksen
    Lecturer
    Lead Specialist, Safety Scientist
    H. Lundbeck A/S
  • Søren Troels Christensen
    Lecturer
    Farmakovigilanceinspektør
    Lægemiddelstyrelsen
See all

Is this course for you?

The course is for new employees in the pharmaceutical industry who want a general understanding of safety and pharmacovigilance, incl. risk management plans, crisis management, audits, and inspections. You will also benefit from the course if you work in a pharmacovigilance role, e.g. if you collaborate with people in clinical development on reporting side effects.

What you will learn

  1. The basic principles and elements of pharmacovigilance
  2. The essential terminology and information sources
  3. How to use best practices in drug safety and pharmacovigilance working processes
  4. How to prepare adverse event reports and the appropriate pharmacovigilance working methods

What your company will get

  1. A safety and pharmacovigilance professional who understands the basic principles and elements of pharmacovigilance
  2. A safety and pharmacovigilance professional who can operate in a dynamic and changing environment
  3. A safety and pharmacovigilance professional who can provide valuable input to all other team members working with drug safety and pharmacovigilance

Course calendar

Choose your starting date
Starting 1 Nov 2023
Starting 27 May 2024
Starting 11 Nov 2024
1 Nov 2023 9:00-16:00

Day 1

  • Regulations and guidelines
  • Qualified Person Responsible for Pharmacovigilance’s (QPPV) role and responsibility
  • System master file
  • Handling of Individual Case Study Report (ICSR), including licensing partners and pharmacovigilance (PV) agreements
  • Product safety information
  • Workshop
2 Nov 2023 9:00-16:00

Day 2

  • Periodic Safety Update Report (PSUR)
  • Clinical development
  • Clinical Trials Directive
  • Non-interventional studies and post-authorization safety studies
  • MedDRA coding
  • Workshop
3 Nov 2023 9:00-16:00

Day 3

  • Development Safety Update Report (DSUR)
  • Signal detection
  • Crisis management
  • Risk management plans
  • Inspections
  • How to prepare for audits and inspections
Practical information

Registration

Registration deadline
25 Oct 2023
Atrium
Lersø Parkallé 101
2100 København Ø
Register
1 - 3 Nov
27 May 2024 9:00-16:00

Day 1

  • Regulations and guidelines
  • Qualified Person Responsible for Pharmacovigilance’s (QPPV) role and responsibility
  • System master file
  • Handling of Individual Case Study Report (ICSR), including licensing partners and pharmacovigilance (PV) agreements
  • Product safety information
  • Workshop
28 May 2024 9:00-16:00

Day 2

  • Periodic Safety Update Report (PSUR)
  • Clinical development
  • Clinical Trials Directive
  • Non-interventional studies and post-authorization safety studies
  • MedDRA coding
  • Workshop
29 May 2024 9:00-16:00

Day 3

  • Development Safety Update Report (DSUR)
  • Signal detection
  • Crisis management
  • Risk management plans
  • Inspections
  • How to prepare for audits and inspections
Practical information

Registration

Registration deadline
20 May 2024
Atrium
Lersø Parkallé 101
2100 København Ø
Register
27 - 29 May
11 Nov 2024 9:00-16:00

Day 1

  • Regulations and guidelines
  • Qualified Person Responsible for Pharmacovigilance’s (QPPV) role and responsibility
  • System master file
  • Handling of Individual Case Study Report (ICSR), including licensing partners and pharmacovigilance (PV) agreements
  • Product safety information
  • Workshop
12 Nov 2024 9:00-16:00

Day 2

  • Periodic Safety Update Report (PSUR)
  • Clinical development
  • Clinical Trials Directive
  • Non-interventional studies and post-authorization safety studies
  • MedDRA coding
  • Workshop
13 Nov 2024 9:00-16:00

Day 3

  • Development Safety Update Report (DSUR)
  • Signal detection
  • Crisis management
  • Risk management plans
  • Inspections
  • How to prepare for audits and inspections
Practical information

Registration

Registration deadline
4 Nov 2024
Atrium
Lersø Parkallé 101
2100 København Ø
Register
11 - 13 Nov
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

Examination

There is no examination for this course.

Course leader

Mette Philipsen
Cluster Safety Lead
Pfizer ApS

Lecturers

Berit Nautrup Andersen
Lead Specialist - QMS, Training and PV Intelligence
H. Lundbeck A/S
Claudia Pierleoni-Nielsen
Director, Head of Safety Surveillance, Global Safety
Leo Pharma A/S
Jannik Høvring Nielsen
Safety Surveillance Principal Specialist, Global Safety
Novo Nordisk A/S
Jeannett Dimsits
Partner
InnoStrat ApS
Kishore Saha
Chief Specialist - Global Patient Safety
H. Lundbeck A/S
Line Alleslev Larsen
Senior Pharmacovigilance Specialist
KLIFO A/S
Mette Stie Kallesøe
Head of Pharmacovigilance QPPV
Hansa Biopharma AB
Morten Gaardlykke
Head of Regulatory Affairs Denmark & Iceland
Pfizer ApS
Peter Eriksen
Lead Specialist, Safety Scientist
H. Lundbeck A/S
Søren Troels Christensen
Farmakovigilanceinspektør
Lægemiddelstyrelsen

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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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